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The effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease

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History
# Registration date Revision Id
2 2024-11-29, 1403/09/09 323101
1 2023-07-09, 1402/04/18 270856
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  • Protocol summary

    Determining the effect of bromelain supplementation on disease activity, quality of life and fecal calprotectin in patients with inflammatory bowel disease
    Determining the effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease
    تعیین اثر مکمل بروملین بر میزان فعالیت بیماری، کیفیت زندگی و کالپروتکتین مدفوعی در بیماران مبتلا به بیماری التهابی روده
    تعیین اثر مکمل بروملین بر میزان فعالیت بیماری و کیفیت زندگی در بیماران مبتلا به بیماری التهابی روده
    A clinical trial with a control group, parallel groups, triple blind, randomized based on blocks of four on 84 patients.
    A clinical trial with a control group, parallel groups, triple blind, randomized on 84 patients.
    کارآزمایی بالینی دارای گروه کنترل، گروه های موازی، سه سوکور، تصادفی شده بر اساس بلوک های چهارتایی بر روی 84 بیمار
    کارآزمایی بالینی دارای گروه کنترل، گروه های موازی، سه سوکور، تصادفی شده بر روی 84 بیمار
    Inclusion criteria: Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's; Minimum age of 18 years and maximum of 70 years Exclusion criteria: The consumption of anti-depressant drugs; anti-coagulant drugs; anti-tumor necrosis factor alpha; The consumption of steroidal and non-steroidal anti-inflammatory drugs; antibiotics; fiber or probiotic during two weeks before the intervention; Pregnancy and breastfeeding; Diseases that have a confounder effect on the results.
    Inclusion criteria: Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's; Minimum age of 18 years and maximum of 70 years Exclusion criteria: The use of anticoagulants, anti-tumor necrosis factor-alpha drugs, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, fiber, and probiotics within two weeks prior to the intervention, pregnancy and lactation, as well as any diseases that may confound the results.
    معیار های ورود شامل: داشتن فعالیت بیماری خفیف تا متوسط در کولیت اولسراتیو و فعالیت بیماری خفیف تا متوسط در کرون، سن حداقل 18 سال و حداکثر 70 سال معیارهای عدم ورود شامل: مصرف داروهای ضد افسردگی، ضد انعقاد، ضد فاکتور نکروز توموری آلفا، مصرف داروهای ضد التهاب استروئیدی و غیر استروئیدی، آنتی بیوتیک، فیبر و پروبیوتیک در طول دو هفته قبل از مداخله، حاملگی و شیردهی، بیماری هایی که اثر مخدوشگری بر نتایج داشته باشند.
    معیار های ورود شامل: داشتن فعالیت بیماری خفیف تا متوسط در کولیت اولسراتیو و فعالیت بیماری خفیف تا متوسط در کرون، سن حداقل 18 سال و حداکثر 70 سال معیارهای عدم ورود شامل: مصرف داروهای ضد انعقاد، ضد فاکتور نکروز توموری آلفا، مصرف داروهای ضد التهاب استروئیدی و غیر استروئیدی، آنتی بیوتیک، فیبر و پروبیوتیک در طول دو هفته قبل از مداخله، حاملگی و شیردهی، بیماری هایی که اثر مخدوشگری بر نتایج داشته باشند.
    Intervention group: They will receive two 500 mg capsules containing bromelain manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks. Control group: They will receive two 500 mg capsules containing maltodextrin manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks.
    Intervention group: They will receive two 500 (gdu) capsules containing bromelain manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks. Control group: They will receive two 500 mg capsules containing maltodextrin manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks.
    گروه مداخله: روزانه 2 عدد کپسول 500 میلی گرمی حاوی بروملین ساخت شرکت داروسازی سلامت پرمون امین را 1 ساعت قبل یا دو ساعت بعد از غذا به مدت 8 هفته دریافت خواهند کرد. گروه کنترل: روزانه 2 عدد کپسول 500 میلی گرمی حاوی مالتودکسترین ساخت شرکت داروسازی سلامت پرمون امین را 1 ساعت قبل یا دو ساعت بعد از غذا به مدت 8 هفته دریافت خواهند کرد.
    گروه مداخله: روزانه 2 عدد کپسولgdu) 500) حاوی بروملین ساخت شرکت داروسازی سلامت پرمون امین را 1 ساعت قبل یا دو ساعت بعد از غذا به مدت 8 هفته دریافت خواهند کرد. گروه کنترل: روزانه 2 عدد کپسول 500 میلی گرمی حاوی مالتودکسترین ساخت شرکت داروسازی سلامت پرمون امین را 1 ساعت قبل یا دو ساعت بعد از غذا به مدت 8 هفته دریافت خواهند کرد.
    Ulcerative colitis and Crohn's disease activity ؛ Quality of life in inflammatory bowel disease ؛ Fecal calprotectin level
    Ulcerative colitis and Crohn's disease activity and Quality of life in inflammatory bowel disease
    فعالیت بیماری کولیت اولسراتیو و کرون؛ کیفیت زندگی در بیماری التهابی روده؛ میزان کالپروتکتین مدفوعی
    فعالیت بیماری کولیت اولسراتیو و کرون و کیفیت زندگی در بیماری التهابی روده

  • General information

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    Due to the high costs of measuring fecal calprotectin, the lack of necessary cooperation by laboratories, and the few laboratories that measure the aforementioned factor, and considering that this factor was not the main outcome of the present study and the sample size was not calculated accordingly, with the opinion of the respected professors of the Nutrition Department and receipt of research approval, as well as adjustment of the study entry and exit criteria with the opinion of the respected consulting physician, this update is required to fully align the information with the updated version of the proposal in the Research Assistant system.
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    به علت هزینه های بالای اندازه گیری فاکتور کالپروتکتین مدفوعی، عدم همکاری لازم توسط آزمایشگاه ها و معدود بودن آزمایشگاه هایی که فاکتور مذکور را اندازه گیری می کنند و با توجه به این که این فاکتور پیامد اصلی مطالعه حاضر نبوده و حجم نمونه نیز بر این اساس محاسبه نشده است، با نظر اساتید محترم گروه تغذیه و دریافت تاییدیه پژوهشی و همچین تعدیل معیارهای ورود و خروج از مطالعه با نظر پزشک مشاور محترم، این به روز رسانی جهت تطابق کامل اطلاعات با نسخه به روز رسانی شده پروپوزال در سامانه پژوهشیار الزامی است.
    The effect of bromelain supplementation on disease activity, quality of life and fecal calprotectin level in patients with inflammatory bowel disease
    The effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease
    اثر مکمل بروملین بر میزان فعالیت بیماری، کیفیت زندگی و کالپروتکتین مدفوعی در بیماران مبتلا به بیماری التهابی روده
    اثر مکمل بروملین بر میزان فعالیت بیماری و کیفیت زندگی در بیماران مبتلا به بیماری التهابی روده
    Smoking
    Alcohol consumption in the last 1 month
    Pregnancy and breastfeeding
    The consumption of antioxidant, vitamin and mineral supplements in the last 2 months
    The consumption of antidepressants
    The consumption of anticoagulant drugs
    The consumption of drugs against tumor necrosis factor alpha
    The consumption of steroidal and non-steroidal anti-inflammatory agents, antibiotics, fiber, probiotic during the two weeks before the intervention.
    Having kidney diseases
    Having liver diseases
    Having thyroid diseases
    Having diabetes
    Having hypotension and hypertension
    Having cardiovascular disease
    Having Biliary diseases
    Having endocrine diseases
    Having mental disorders or neurological diseases
    Having Cushing's syndrome
    Having polycystic ovary syndrome
    Having anemia
    Having hemophilia
    Having leukopenia
    Having thrombocytopenia
    Having asthma
    Having cancer
    Having anorexia and bulimia nervosa
    Having autoimmune diseases
    Having gastroesophageal reflux disease
    Other gastrointestinal diseases and extensive gastrointestinal surgeries that affect the condition of the disease
    Having other chronic inflammatory and autoimmune diseases according to the physician diagnosis
    Smoking
    Alcohol consumption in the last 1 month
    Pregnancy and breastfeeding
    The consumption of antioxidant supplements such as Vitamin C, Vitamin E, Selenium, Curcumin, Pomegranate Peel, or any other antioxidant supplements in the last 1 month
    The consumption of anticoagulant drugs
    The consumption of drugs against tumor necrosis factor alpha
    The consumption of steroidal and non-steroidal anti-inflammatory agents, antibiotics, fiber, probiotic during the two weeks before the intervention.
    Patients in the stage of Vitamin D deficiency.
    Suffering from other chronic inflammatory diseases, mental disorders, or neurological diseases (such as Parkinson's, Alzheimer's, intracranial hemorrhage, head or brain injury), Cushing's syndrome, polycystic ovary syndrome, anemia, hemophilia, leukopenia, thrombocytopenia, asthma, cancer, anorexia nervosa, bulimia nervosa, other autoimmune diseases, and major gastrointestinal surgeries that may affect the condition under study.
    مصرف دخانیات
    مصرف الکل در کمتر از 1 ماه اخیر
    حاملگی و شیردهی
    مصرف مکمل های آنتی اکسیدان، ویتامین و املاح در 2 ماه اخیر
    دریافت داروهای ضد افسردگی
    مصرف داروهای ضد انعقاد
    مصرف داروهای ضد فاکتومور نکروز آلفا
    مصرف داروهای ضد التهاب استروئیدی و غیر استروئیدی، آنتی بیوتیک، فیبر و پروبیوتیک در طول دو هفته قبل از شروع مداخله
    ابتلا به بیماری های کلیوی
    ابتلا به بیماری های کبدی
    ابتلا به بیماری‌های تیروئیدی
    ابتلا به بیماری دیابت
    ابتلا به فشار خون پایین یا پرفشاری خون
    ابتلا به بیماری‌های قلبی - عروقی
    ابتلا به بیماری های صفراوی
    ابتلا به بیماری‌های غدد درون‌ریز
    ابتلا به اختلالات روانی یا بیماری‌های عصبی
    ابتلا به بیماری سندرم کوشینگ
    ابتلا به بیماری سندرم تخمدان پلی کیستیک
    ابتلا به بیماری کم‌خونی
    ابتلا به بیماری هموفیلی
    ابتلا به بیماری لکوپنی
    ابتلا به بیماری ترومبوسایتوپنی
    ابتلا به بیماری آسم
    ابتلا به بیماری سرطان
    ابتلا به بیماری بی اشتهای و پرخوری عصبی
    ابتلا به بیماری های خود ایمنی
    ابتلا به بیماری رفلاکس معدی-مروی
    سایر بیماری های گوارشی و جراحی های وسیع گوارشی که بر وضعیت بیماری مورد نظر اثر داشته باشند
    ابتلا به سایر بیماری های التهابی مزمن و خودایمنی طبق تشخیص پزشک
    مصرف دخانیات
    مصرف الکل در کمتر از 1 ماه اخیر
    حاملگی و شیردهی
    مصرف مکمل های آنتی اکسیدان مانند ویتامین C، E، سلنیوم، کورکومین، پوست انار و هر گونه مکمل آنتی اکسیدان دیگر در ۱ ماه اخیر
    مصرف داروهای ضد انعقاد
    مصرف داروهای ضد فاکتومور نکروز آلفا
    مصرف داروهای ضد التهاب استروئیدی و غیر استروئیدی، آنتی بیوتیک، فیبر و پروبیوتیک در طول دو هفته قبل از شروع مداخله
    بیمارانی در مرحله کمبود ویتامین D
    ابتلا به سایر بیماری های التهابی مزمن، اختلالات روانی یا بیماری‌های عصبی (‏پارکینسون، آلزایمر، خونریزی داخل جمجمه، سر یا آسیب مغزی)‏، سندرم کوشینگ، سندرم تخمدان پلی کیستیک، کم‌خونی، هموفیلی، لکوپنی، ترومبوسایتوپنی، آسم، سرطان، بی اشتهای و پرخوری عصبی، سایر بیماری های خود ایمنی و جراحی های وسیع گوارشی که بر وضعیت بیماری مورد نظر اثر داشته باشند.
    Patients with the inclusion criteria will be assigned to groups A or B based on a randomized list generated by using the technique of quadruple blocks procured from a software application known as Random Number Calculator. For the production of placebo, coordination will be made with Salamat Parmon Amin manufacturing company. It is requested that the drug manufacturer label the drug or placebo with a letter A or B, determined by a coin toss, and the opposite letter shall be assigned to the alternative option.
    Patients meeting the study's inclusion criteria will be allocated to group A or B according to a randomized list generated by the Random Number Calculator software, based on the order of their enrollment. Coordination will be established with Salamat Parmoun Amin pharmaceutical company for the preparation of the placebo. The drug manufacturer will be requested to assign one of the letters (A or B) to the drug and the other to the placebo using a coin toss for randomization.
    بیماران دارای شرایط ورود به مطالعه، براساس لیست تصادفی شده (به روش بلوک های چهارتایی حاصل از برنامه کامپیوتری Random number calculator ) در گروه‌های A یا B به ترتیب مراجعه قرار خواهند گرفت. جهت ساخت دارونما با شرکت تولیدی سلامت پرمون امین هماهنگی انجام خواهد شد و درخواست می‌گردد که سازنده دارو با استفاده از قرعه کشی توسط پرتاب سکه، یکی از حروف A یا B را بر دارو یا دارونما و حرف دیگر را بر روی دیگری قرار دهند.
    بیماران دارای شرایط ورود به مطالعه، براساس لیست تصادفی شده ( حاصل از برنامه کامپیوتری Random number calculator) در گروه‌های A یا B به ترتیب مراجعه قرار خواهند گرفت. جهت ساخت دارونما با شرکت تولیدی سلامت پرمون امین هماهنگی انجام خواهد شد و درخواست می‌گردد که سازنده دارو با استفاده از قرعه کشی توسط پرتاب سکه، یکی از حروف A یا B را بر دارو یا دارونما و حرف دیگر را بر روی دیگری قرار دهند.

  • Secondary outcomes

    #1
    Fecal calprotectin level
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    میزان کالپروتکتین مدفوعی
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    Before the intervention and 8 weeks after the intervention
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    قبل از مداخله و 8 هفته بعد از مداخله
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    Fecal calprotectin measurement kit
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    کیت اندازه گیری کالپروتکتین مدفوعی
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  • Intervention groups

    #1
    Intervention group: They will receive 2 capsules of 500 mg containing bromelain manufactured by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food.
    Intervention group: They will receive 2 capsules of 500 (gdu) containing bromelain manufactured by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food.
    گروه مداخله: روزانه 2 عدد کپسول 500 میلی گرمی حاوی بروملین ساخت شرکت سلامت پرمون امین به مدت 8 هفته 1 ساعت قبل یا دو ساعت بعد از غذا دریافت خواهند کرد.
    گروه مداخله: روزانه 2 عدد کپسول 500 (gdu) حاوی بروملین ساخت شرکت سلامت پرمون امین به مدت 8 هفته 1 ساعت قبل یا دو ساعت بعد از غذا دریافت خواهند کرد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Hazrat Rasool Akram Hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: seyedeh tayebeh rahideh
    Full name of responsible person - Persian: سیده طیبه رهیده
    Street address - English: Hazrat Rasool Akram Hospital, corner of Mansouri St., Niayesh St., Sattar Khan St.
    Street address - Persian: خیابان ستارخان ، خیابان نیایش ، نبش خیابان منصوری ، بیمارستان حضرت رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6435 1000
    Fax:
    Email: Rasoolhospital@iums.ac.ir
    Web page address:
    Name of recruitment center - English: Hazrat Rasool Akram Hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: Seyedeh Tayebeh Rahideh
    Full name of responsible person - Persian: سیده طیبه رهیده
    Street address - English: Hazrat Rasool Akram Hospital, Corner of Mansouri St., Niayesh St., Sattar Khan St.
    Street address - Persian: خیابان ستارخان ، خیابان نیایش ، نبش خیابان منصوری ، بیمارستان حضرت رسول اکرم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6435 1000
    Fax:
    Email: Rasoolhospital@iums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: seyedeh tayebeh rahideh
    Full name of responsible person - Persian: سیده طیبه رهیده
    Street address - English: Iran University of Medical Sciences, next to Milad Tower, Hemet Highway
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 86701
    Fax:
    Email: iumspr@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Reza Falak
    Full name of responsible person - Persian: رضا فلک
    Street address - English: The Headquarters of University, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
    Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران، ستاد مرکزی دانشگاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 3072
    Fax:
    Email: rezafalak@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease
Design
A clinical trial with a control group, parallel groups, triple blind, randomized on 84 patients.
Settings and conduct
The study will be conducted in a triple-blind manner (patient, therapist and analyst) in Hazrat Rasool Akram Hospital. People's food intake is evaluated with a 24-hour recal. Scores of disease activity questionnaires in ulcerative colitis and Crohn's disease, quality of life and international physical activity will be evaluated before and after the intervention. Stool samples will be taken from patients before and after the intervention. Nutrient analysis will be done using N4 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's; Minimum age of 18 years and maximum of 70 years Exclusion criteria: The use of anticoagulants, anti-tumor necrosis factor-alpha drugs, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, fiber, and probiotics within two weeks prior to the intervention, pregnancy and lactation, as well as any diseases that may confound the results.
Intervention groups
Intervention group: They will receive two 500 (gdu) capsules containing bromelain manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks. Control group: They will receive two 500 mg capsules containing maltodextrin manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks.
Main outcome variables
Ulcerative colitis and Crohn's disease activity and Quality of life in inflammatory bowel disease

General information

Reason for update
Due to the high costs of measuring fecal calprotectin, the lack of necessary cooperation by laboratories, and the few laboratories that measure the aforementioned factor, and considering that this factor was not the main outcome of the present study and the sample size was not calculated accordingly, with the opinion of the respected professors of the Nutrition Department and receipt of research approval, as well as adjustment of the study entry and exit criteria with the opinion of the respected consulting physician, this update is required to fully align the information with the updated version of the proposal in the Research Assistant system.
Acronym
IRCT registration information
IRCT registration number: IRCT20191105045340N2
Registration date: 2023-07-09, 1402/04/18
Registration timing: prospective

Last update: 2024-12-07, 1403/09/17
Update count: 1
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Seyedeh Tayebeh Rahideh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4843
Email address
rahide.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
The effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease
Public title
The effect of bromelain in inflammatory bowel disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of inflammatory bowel disease based on the diagnosis of a gastroenterologist Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's Minimum age of 18 years and maximum of 70 years People express their satisfaction to participate in the study
Exclusion criteria:
Smoking Alcohol consumption in the last 1 month Pregnancy and breastfeeding The consumption of antioxidant supplements such as Vitamin C, Vitamin E, Selenium, Curcumin, Pomegranate Peel, or any other antioxidant supplements in the last 1 month The consumption of anticoagulant drugs The consumption of drugs against tumor necrosis factor alpha The consumption of steroidal and non-steroidal anti-inflammatory agents, antibiotics, fiber, probiotic during the two weeks before the intervention. Patients in the stage of Vitamin D deficiency. Suffering from other chronic inflammatory diseases, mental disorders, or neurological diseases (such as Parkinson's, Alzheimer's, intracranial hemorrhage, head or brain injury), Cushing's syndrome, polycystic ovary syndrome, anemia, hemophilia, leukopenia, thrombocytopenia, asthma, cancer, anorexia nervosa, bulimia nervosa, other autoimmune diseases, and major gastrointestinal surgeries that may affect the condition under study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Patients meeting the study's inclusion criteria will be allocated to group A or B according to a randomized list generated by the Random Number Calculator software, based on the order of their enrollment. Coordination will be established with Salamat Parmoun Amin pharmaceutical company for the preparation of the placebo. The drug manufacturer will be requested to assign one of the letters (A or B) to the drug and the other to the placebo using a coin toss for randomization.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This interventional study will be conducted in a triple blind manner. Blinding includes patient, therapist and analyst. In order to make a placebo, coordination will be done with Salamat Parmon Amin production company and it is requested that the drug manufacturer put one of the letters A or B on the drug or placebo and the other letter on the other by using a lottery by throwing a coin. The confidentiality of both the drug and placebo types should be maintained until the conclusion of the data analysis, as a fundamental element of the research protocol, and after the analysis, the researcher will ask the person in charge of the drug manufacturing for the type of labels. This means that the therapist will not know the type of medicine or whether the medicine packages are placebo. Neither the patient nor the analyst will know about this. The placebo capsules will bear complete resemblance to the capsules of the intervention group in terms of their coating, color, and smell
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Management of Research Development and Evaluation, Deputy of research and technology, next to Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.IUMS.REC.1402.125

Health conditions studied

1

Description of health condition studied
Crohn's disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]

2

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Ulcerative colitis disease activity questionnaire score
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Ulcerative Colitis disease Activity Evaluation Questionnaire

2

Description
Crohn disease activity questionnaire score
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Crohn disease Activity Evaluation Questionnaire

Secondary outcomes

1

Description
Quality of life questionnaire score in inflammatory bowel disease
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Quality of life assessment questionnaire in inflammatory bowel disease

Intervention groups

1

Description
Intervention group: They will receive 2 capsules of 500 (gdu) containing bromelain manufactured by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food.
Category
Treatment - Other

2

Description
Control group: They will receive 2 capsules of 500 mg containing maltodextrin made by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Seyedeh Tayebeh Rahideh
Street address
Hazrat Rasool Akram Hospital, Corner of Mansouri St., Niayesh St., Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasoolhospital@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
The Headquarters of University, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 3072
Email
rezafalak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Tayebeh Rahideh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutritional Sciences, Faculty of Health, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4843
Email
tayebeh_rahideh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Tayebeh Rahideh
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4843
Fax
Email
rahide.t@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Tayebeh Rahideh
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4843
Fax
Email
tayebeh_rahideh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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