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the effect of gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100524004010N29
Enrollment
50
Registered
2020-06-01
Start date
2020-07-10
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: 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 plu

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

Exclusion criteria: consumption of artificial sweeteners(effet on intestinal permeability) 2 days before entering the study not agree to entering the study

Design outcomes

Primary

MeasureTime frame
Quality of life. Timepoint: Beginning and end of study. Method of measurement: Irritable Bowel Syndrome Quality of Life Quality of Life Questionnaire.

Secondary

MeasureTime frame
Irritable Bowel Syndrome- Symptom Severity Score. Timepoint: Beginning and end of study. Method of measurement: Questionnaire (IBS_SSS).;Abdominal pain intensity. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale.;Abdominal pain frequency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire.;Abdominal distention. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale.;Satisfaction with bowel habits. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale.;Interference with community function. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale.;Defecation frequency. Timepoint: Beginning and end of study. Method of measurement: Questinnaire.;Defecation consistency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzita Hekmatdoost

Shahid Beheshti University of Medical Sciences

a_hekmat2000@yahoo.com+98 21 2293 0824

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 20, 2026