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The effect of low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet with and without gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome

Protocol summary

Study aim
The effect of low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet with and without gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome
Design
A randomized, blinded, controlled clinical trial with a parallel group، design of 501 patients, , and the table of random numbers was used for the randomization.
Settings and conduct
patients with irritable bowel syndrome referring to Erfan Hospital, if they wish to participate in the study informed consent of them will be taken. Patients were randomized to receive a l-glutamine plus a low FODMAP diet or low FODMAP diet (and placebo) for 6 weeks. Before and after the intervention blood sample will be collected and scores will be evaluated for IBS symptoms. the study is double blind
Participants/Inclusion and exclusion criteria
ages 18-65; Patients with irritable bowel syndrome; Body Mass Index in range (18-25); Lack of any organic intestinal disease and intestinal infection; No medical history of chronic gastrointestinal and colorectal disease; Lack of any major bowel surgery; Lack of medical history of liver and kidney disorders; No regular use of laxative and anti-diarrhea medications.
Intervention groups
In this study، patients will receive supplement or placebo with a low FODMAP diet for 6 weeks depending on the group they are in. patients in the supplement group will receive 5gr of gluten and the placebo group will recevie the 5 gr of rice flour which is similar in shape and color to the supplement , once a day and in the form of dissolved in 230 ml of water.
Main outcome variables
Abdominal pain intensity, Abdominal pain frequency, Abdominal distension, Satisfaction with bowel habits, Interference with community function, Defecation frequency, Defecation consistency, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004010N29
Registration date: 2020-06-01, 1399/03/12
Registration timing: prospective

Last update: 2020-06-01, 1399/03/12
Update count: 0
Registration date
2020-06-01, 1399/03/12
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet with and without gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome
Public title
the effect of gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years Patients with irritable bowel syndrome, according to a gastroenterologist diagnosed according to ROME IV criteria (having at least one day a week over the past 3 months for at least two of the following: 1- related to Defecation; 2- related to the frequency of defecation, 3- related to changes in stool shape and consistency, and no pathological findings in gastrointestinal Body Mass Index in range (18-25) Lack of any organic intestinal disease ( diagnosed by last 5 years ago colonoscopy) and intestinal infection (diagnosed by stool culture) Lack of medical history of chronic gasrtointestinal and colorectal disease Lack of any major bowel surgery Absence of regular use of laxatives or anti diarreheal drugs No chronic use of corticosteroids and immunosuppressants No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylates No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin and heparin Lack of pregnancy or breastfeeding،athlete or hospitalization Absence of severe mental or behavioral disorder Absence of nicotine and its derivatives use in the last 6 months No usage of NSAIDs and aspirin in last week (effect on gut permeability)
Exclusion criteria:
consumption of artificial sweeteners(effet on intestinal permeability) 2 days before entering the study not agree to entering the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study، in order to the randomization process، a simple randomization is used by using a table of random numbers.before begining the study،each person is placed in one of the intervention or placebo groups based on a simple random division table.we have considered a two-digit code for the number of sample size numbers, and selected the start point by referring to the table, and based on the adjacent two-digit number, moved in the direction of the row, and we choose the first two-digit number less than 50 as the first smple and we'll continue to do this until the samples reach 50.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study، patients will receive supplement or placebo with a low FODMAP diet for 6 weeks depending on the group they are in. patients in the supplement group will receive 5gr of gluten and the placebo group will recevie the 5 gr of rice flour which is similar in shape and color to the supplement , once a day and in the form of dissolved in 230 ml of water. group A and group B to the purpose of not informing the researcher of the type of powder used by each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethicts committe of Shahid Beheshti University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafshan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1399.010

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Quality of life
Timepoint
Beginning and end of study
Method of measurement
Irritable Bowel Syndrome Quality of Life Quality of Life Questionnaire

Secondary outcomes

1

Description
Irritable Bowel Syndrome- Symptom Severity Score
Timepoint
Beginning and end of study
Method of measurement
Questionnaire (IBS_SSS)

2

Description
Abdominal pain intensity
Timepoint
Beginning and end of study
Method of measurement
Visual Analogue Scale

3

Description
Abdominal pain frequency
Timepoint
Beginning and end of study
Method of measurement
Questionnaire

4

Description
Abdominal distention
Timepoint
Beginning and end of study
Method of measurement
Visual Analogue Scale

5

Description
Satisfaction with bowel habits
Timepoint
Beginning and end of study
Method of measurement
Visual Analogue Scale

6

Description
Interference with community function
Timepoint
Beginning and end of study
Method of measurement
Visual Analogue Scale

7

Description
Defecation frequency
Timepoint
Beginning and end of study
Method of measurement
Questinnaire

8

Description
Defecation consistency
Timepoint
Beginning and end of study
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Patients in the intervention group will receive 5 gr gluten powder (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study.
Category
Other

2

Description
Control group: Patients in the control group will receive 5 gr rice flur (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Erfan Hospital
Full name of responsible person
Shahram Agah
Street address
Erfan Hospital, Shahid Riazi Bakhshayesh St., sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2302 1000
Email
info@erfanhospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
No.7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nutrition@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
West Arghavan, Shahrak Gharb
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2293 0824
Email
a_hekmat2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No.7, Wast Arghavan .,Farahzadi Blvd.,Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2293 0824
Email
a_hekmat2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mohseni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 7, Mikhak Dead End ,The First of Eqbal Pur St.,Simon Bolivar Blvd., The End of Ashrafi Esfehani Hwy, Punak
City
Tehran
Province
Tehran
Postal code
1477773683
Phone
+98 21 4480 0079
Email
fh.mohseni73@gmail.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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