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Protocol summary
150 patients will participate in the study, in three groups: non-probiotic yogurt, probiotic yogurt and omeprazole group with 50 patients in each group.
Randomization will be based on Permuted Block Randomization
120 patients will participate in the study, in three groups: non-probiotic yogurt, probiotic yogurt and omeprazole group with 40 patients in each group.
Randomization will be based on Permuted Block Randomization
150120 patients will participate in the study, in three groups: non-probiotic yogurt, probiotic yogurt and omeprazole group with 5040 patients in each group. Randomization will be based on Permuted Block Randomization
150 بیمار در مطالعه شرکت خواهند کرد، در سه گروه ماست معمولی، ماست پروبیوتیک و داروی امپرازول که حجم نمونه در هر گروه 50 نفر می باشد.
تصادفی سازی بر اساس بلوک های جایگشتی (permuted block randomization) انجام می شود.
120 بیمار در مطالعه شرکت خواهند کرد، در سه گروه ماست معمولی، ماست پروبیوتیک و داروی امپرازول که حجم نمونه در هر گروه 40 نفر می باشد.
تصادفی سازی بر اساس بلوک های جایگشتی (permuted block randomization) انجام می شود.
150120 بیمار در مطالعه شرکت خواهند کرد، در سه گروه ماست معمولی، ماست پروبیوتیک و داروی امپرازول که حجم نمونه در هر گروه 5040 نفر می باشد. تصادفی سازی بر اساس بلوک های جایگشتی (permuted block randomization) انجام می شود.
Colony counts of the intestinal flora in the patient's stool sample
Intensity of reflux
evaluation of quality of life
Intensity of reflux
Colony countsevaluation of the intestinal flora in the patient's stool samplequality of life Intensity of reflux
شمارش کلونی های فلور روده در نمونه مدفوع بیماربررسی کیفیت زندگی شدت ریفلاکس
General information
150
120
150120
empty
Modifying the sample size and secondary outcome
Modifying the sample size and secondary outcome
empty
اصلاح حجم نمونه و متغیر ثانویه
اصلاح حجم نمونه و متغیر ثانویه
Secondary outcomes
#1
Counting colonies of intestinal flora in the patient stool
Assessment of quality of life
Counting coloniesAssessment of intestinal flora in the patient stoolquality of life
شمارش کلونی های فلور روده در نمونه استول بیمار
بررسی کیفیت زندگی
شمارش کلونی های فلور روده در نمونه استول بیماربررسی کیفیت زندگی
Stool culture test
questionnaire
Stool culture testquestionnaire
کشت نمونه مدفوع
پرسشنامه
کشت نمونه مدفوعپرسشنامه
Recruitment centers
#1
Name of recruitment center - English: Gastrointestinal Clinic of Imam Hassan Hospital
Name of recruitment center - Persian: کلینیک گوارش بیمارستان امام حسن(ع)
Full name of responsible person - English: Dr. Seyyed Javad Pour Naghi
Full name of responsible person - Persian: دکتر سید جواد پور نقی
Street address - English: Bojnourd - Imam Hassan Hospital - Class 4
Street address - Persian: بجنورد - بیمارستان امام حسن(ع )-طبقه 4
City - English: bojnourd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9418655459
Phone: +98 58 3151 4241
Fax:
Email: pournaghij861@yahoo.com
Web page address:
Name of recruitment center - English: Gastrointestinal Clinic of Imam Hassan Hospital
Name of recruitment center - Persian: کلینیک گوارش بیمارستان امام حسن(ع)
Full name of responsible person - English: Dr. Seyyed Javad Pour Naghi
Full name of responsible person - Persian: دکتر سید جواد پور نقی
Street address - English: Bojnourd - Imam Hassan Hospital - Class 4
Street address - Persian: بجنورد - بیمارستان امام حسن(ع )-طبقه 4
City - English: Bojnourd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9418655459
Phone: +98 58 3151 4241
Fax:
Email: pournaghij861@yahoo.com
Web page address:
Name of recruitment center - English: Gastrointestinal Clinic of Imam Hassan Hospital Name of recruitment center - Persian: کلینیک گوارش بیمارستان امام حسن(ع) Full name of responsible person - English: Dr. Seyyed Javad Pour Naghi Full name of responsible person - Persian: دکتر سید جواد پور نقی Street address - English: Bojnourd - Imam Hassan Hospital - Class 4 Street address - Persian: بجنورد - بیمارستان امام حسن(ع )-طبقه 4 City - English: bojnourdBojnourd City - Persian: بجنورد Province: North Khorasan Country: Iran (Islamic Republic of) Postal code: 9418655459 Phone: +98 58 3151 4241 Fax: Email: pournaghij861@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: dr.seyed javad pour naghi
Full name of responsible person - Persian: دکتر سید جواد پور نقی
Street address - English: Bojnourd - Behind Imam Ali Hospital - Deputy of Research and Technology
Street address - Persian: بجنورد- پشت بیمارستان امام علی-معاونت تحقیقات و فن آوری
City - English: bojnourd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9418655459
Phone: +98 58 3151 4241
Fax:
Email: pournaghij861@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Kaveh Hojjat
Full name of responsible person - Persian: دکتر کاوه حجت
Street address - English: Shahriar
Street address - Persian: شهریار
City - English: Bojnurd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9414974877
Phone: +98 21 3229 7182
Fax:
Email: S.Kavehhojjat1@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: dr.seyed javad pour naghiDr. Kaveh Hojjat Full name of responsible person - Persian: دکتر سید جواد پور نقیکاوه حجت Street address - English: Bojnourd - Behind Imam Ali Hospital - Deputy of Research and TechnologyShahriar Street address - Persian: بجنورد- پشت بیمارستان امام علی-معاونت تحقیقات و فن آوریشهریار City - English: bojnourdBojnurd City - Persian: بجنورد Province: North Khorasan Country: Iran (Islamic Republic of) Postal code: 94186554599414974877 Phone: +98 58 3151 424121 3229 7182 Fax: Email: pournaghij861S.Kavehhojjat1@yahoo.comgmail.com Web page address:
Protocol summary
Study aim
The effect of probiotic yogurt consumption on Gastroesophageal reflux disease
Design
120 patients will participate in the study, in three groups: non-probiotic yogurt, probiotic yogurt and omeprazole group with 40 patients in each group.
Randomization will be based on Permuted Block Randomization
Settings and conduct
A clinical trial study (three-blinded for our cohorts), between 2020-21, on patients older than 18 years referred to Gastroenterology Clinics of North Khorasan with gastroesophageal reflux disease (Gastroenterology and Liver). Three treatment modalities (prebiotic yogurt, plain yogurt, omeprazole) are written on cardboards by codes and enclosed in envelopes and will be delivered to the specialist physician in a completely randomized manner.
Participants/Inclusion and exclusion criteria
-Inclusion criteria:
The patient be literate or someone helps him/her in filling the questionnaires;
Patients should be geographically accessible
-Exclusion criteria:
Age less than 18 years;
Allergy to dairy products;
Pregnancy;
History of gastrointestinal malignancy
Intervention groups
There are three treatment groups with three treatments. The first group will consume normal yogurt, the second group will take omoprazole, and the third group will use prebiotic yogurt.
Main outcome variables
evaluation of quality of life
Intensity of reflux
General information
Reason for update
Modifying the sample size and secondary outcome
Acronym
IRCT registration information
IRCT registration number:IRCT20190831044653N4
Registration date:2020-01-30, 1398/11/10
Registration timing:registered_while_recruiting
Last update:2023-03-29, 1402/01/09
Update count:1
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Maryam Rameshrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7182
Email address
mrameshrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of yogurt containing probiotics in treating gastroesophageal reflux disease: a randomized clinical trial
Public title
Evaluating the effects of yogurt containing probiotics in treating gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient be literate or someone helps him/her in filling the questionnaires
Patients should be geographically accessible
Exclusion criteria:
Age less than 18 years
Allergy to dairy products
Pregnancy
History of gastrointestinal malignancy
History of gastric and esophageal surgery and small bowel bypass
Liver and kidney and heart dysfunction
Concomitant use of NSAIDs and aspirin for up to one week before the study
Anticancer or antibiotic use during 4 weeks before referral and participation in this study
No anti-acid, hydrogen pump inhibitors, H2 receptor inhibitors in two groups of yogurt recipients during the study
Receiving bisphosphenate, cortisone, potassium chloride or iron tablets concurrently in the study
Patient's compliance be less than 80% (self-reported by patient)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were randomized based on block permutation methods (permuted block randomization) into the three treatment groups (2 groups (probiotic yogurt and regular yogurt) and a control group).
Based on the result of randomization by Permuted Block Randomization and R software, patients are allocated to groups sequentially in order of their meeting.
The yogurts, both probiotic and simple, will be provided in the same shape single dose containers without any type definer and will be introduced to the drug distributor with unmeaning code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Bojnourd - Behind Imam Ali Hospital - Deputy of Research and Technology
City
bojnourd
Province
North Khorasan
Postal code
9418655459
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.NKUMS.REC.1398.084
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux disease (GERD)
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
effect on the GERD severity
Timepoint
Baseline, one month and tow months later
Method of measurement
The Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (related to typical symptoms)
2
Description
Effect on the severity of GERD atypical symptoms
Timepoint
Baseline, one month and tow months late
Method of measurement
Reflux Symptom Index and Disease Specific Quality of Life Index questionnaires (related to atypical symptoms)
Secondary outcomes
1
Description
Assessment of quality of life
Timepoint
At baseline, one month and tow months later
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Ordinary yogurt
Category
Treatment - Other
2
Description
Intervention group: Probiotics yogurt
Category
Treatment - Other
3
Description
Control group: Omeprazole
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Clinic of Imam Hassan Hospital
Full name of responsible person
Dr. Seyyed Javad Pour Naghi
Street address
Bojnourd - Imam Hassan Hospital - Class 4
City
Bojnourd
Province
North Khorasan
Postal code
9418655459
Phone
+98 58 3151 4241
Email
pournaghij861@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Kaveh Hojjat
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 21 3229 7182
Email
S.Kavehhojjat1@gmail.com
Grant name
Grant, Faculty Member of Bojnourd University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Javad Pournaghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastrointestinal
Street address
Bojnourd - Imam Hassan Hospital - 6th floor
City
Bojnourd
Province
North Khorasan
Postal code
9418655459
Phone
+98 58 3221 0510
Email
pournaghij861@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Javad Pournaghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastrointestinal
Street address
Bojnourd - Imam Hassan Hospital - 6th floor
City
Bojnourd
Province
North Khorasan
Postal code
9418655459
Phone
+98 58 3221 0510
Email
pournaghij861@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Rameshrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahriar Street,
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
rameshrm2@mums.ac.ir
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