Protocol summary
-
Study aim
-
Effect of the low-FODMAP(Fermentable, Oligo-, Di-, Mono-saccharides, and Polyols) diet with L-glutamine supplementation compared with placebo on clinical symptoms, quality of life and intestinal permeability in patients with irritable bowel syndrome
-
Design
-
Randomized Clinical Trial double-blind
-
Settings and conduct
-
patients with irritable bowel syndrome referring to Imam Khomeini 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 18-70; 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
-
patients will receive a 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 L-glutamine powder, and the placebo group will receive the iso whey protein powder which is similar in shape and color to the supplement. (both of them 5 g three times daily 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
-
This update was performed to correct an error in the primary outcome section as well as changes in study design due to the coronavirus pandemic.
The effective time period for receiving the diet and supplement according to previous studies is 6 to 8 weeks. This time was reduced from 8 weeks to 6 weeks to reduce face-to-face visits.
The age range was changed to 18-70. Because the number of patients with irritable bowel syndrome over the age of 60 who refer to gastrointestinal clinics is high.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20100524004010N28
Registration date:
2020-04-11, 1399/01/23
Registration timing:
prospective
Last update:
2021-01-09, 1399/10/20
Update count:
1
-
Registration date
-
2020-04-11, 1399/01/23
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-06-20, 1399/03/31
-
Expected recruitment end date
-
2021-02-18, 1399/11/30
-
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 glutamine supplement versus placebo on clinical outcomes, quality of life and intestinal permeability in patients with irritable bowel syndrome
-
Public title
-
The effect of glutamine on clinical outcomes, quality of life and intestinal permeability in patients with irritable bowel syndrome
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
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 gastrointestinal and colorectal disease
Lack of any major bowel surgery
Lack of medical history of liver disorders
Absence of regular use of laxatives or antidiarrheal drugs
No chronic use of corticosteroids and immunosuppressants
No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate
No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin and heparin
Absence of nicotine and its derivatives use in the last 6 months
No usage of NSAIDs and aspirin in last week (influence on gut permeability)
Absence of severe mental or behavioral disorder
Lack of medical history of kidney disorders
Exclusion criteria:
Not agree to entering the study
Consumption of artificial sweeteners (effect on intestinal permeability) 2 days before entering the study
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
50
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The method used in this study to create a randomization
process is simple randomization, so we utilize random
number table. Beginning of the study, each person is
randomly assigned to one of the 2 study groups
according to the randomized distribution table.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In this study, patients will receive a 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 L-glutamine powder, and the placebo group will receive the iso whey protein powder which is similar in shape and color to the supplement. 5 g three times daily in 230 ml of water.
Before starting the study, powdered cans are coded by a person other than the researcher into 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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-01-04, 1398/10/14
-
Ethics committee reference number
-
IR.SBMU.NNFTRI.REC.1398.083
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
-
Irritable Bowel Syndrome symptom severity score
-
Timepoint
-
Beginning and end of study
-
Method of measurement
-
Irritable Bowel Syndrome symptom severity scale Questionnaire
Secondary outcomes
1
-
Description
-
Quality of life
-
Timepoint
-
Beginning and end of study
-
Method of measurement
-
Irritable bowel syndrome quality of life Questionnaire
2
-
Description
-
serum zonulin
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Elisa kit
3
-
Description
-
Abdominal pain intensity
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Visual Analogue Scale
4
-
Description
-
Abdominal pain frequency
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Questionnaire
5
-
Description
-
Abdominal distension
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Visual Analogue Scale
6
-
Description
-
Satisfaction with bowel habits
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Visual Analogue Scale
7
-
Description
-
Interference with community function
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Visual Analogue Scale
8
-
Description
-
Defecation frequency
-
Timepoint
-
Beginning and end of study
-
Method of measurement
-
Questionnaire
9
-
Description
-
Defecation consistency
-
Timepoint
-
Beginning and end of study
-
Method of measurement
-
Questionnaire
Intervention groups
1
-
Description
-
Intervention group: will receive15 g (5 grams three times a day) L- glutamine supplement plus low FODMAP diet for 6 weeks
-
Category
-
Treatment - Other
2
-
Description
-
Control group: will receive 15 g (5 grams three times a day) iso whey supplement plus low FODMAP diet for 6 weeks
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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