Determining the effect of bromelain supplementation on disease activity, quality of life and fecal calprotectin in patients with inflammatory bowel disease
Design
A clinical trial with a control group, parallel groups, triple blind, randomized based on blocks of four 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 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.
Intervention groups
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.
Main outcome variables
Ulcerative colitis and Crohn's disease activity ؛ Quality of life in inflammatory bowel disease ؛ Fecal calprotectin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191105045340N2
Registration date:2023-07-09, 1402/04/18
Registration timing:prospective
Last update:2023-07-09, 1402/04/18
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bromelain supplementation on disease activity, quality of life and fecal calprotectin level 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, 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
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 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.
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
Nawab Safavi Hostel, side road next to Iran Psychiatric Hospital, next to gas station, km 8 of special road (Shahid Lashkari)
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
2
Description
Fecal calprotectin level
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Fecal calprotectin measurement kit
Intervention groups
1
Description
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.
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
seyedeh tayebeh rahideh
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemet Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
iumspr@iums.ac.ir
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