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
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 8 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
patients will receive a supplement or placebo with a low fodmap diet for 8 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
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N28
Registration date:2020-04-11, 1399/01/23
Registration timing:prospective
Last update:2020-04-11, 1399/01/23
Update count:1
Registration date
2020-04-11, 1399/01/23
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
2020-06-20, 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 65 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 8 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1981619573
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
quality of life
Timepoint
Beginning and end of study
Method of measurement
Irritable Bowel Syndrome Quality of Life Questionnaire
Secondary outcomes
1
Description
Irritable Bowel Syndrome -Symptom Severity Score
Timepoint
Beginning and end of study
Method of measurement
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 8 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 8 weeks