Effect of gluten diet in Irrtable Bowel Syndrome

Comparison of gastrointestinal symptoms use of gluten and gluten free diet in Irritable Bowel Syndrom patients referred to gastrointestinal clinic at Imam Khomeini Hospital during 2012

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013071413996N1

Enrollment

Registered

2013-08-29

Start date

2012-10-12

Completion date

Unknown

Last updated

2018-02-22

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 with Diarrhea

Interventions

Intervention 1: The gluten group is given a packet containing gluten meal (free of fermentable oligo di-monosaccharides and polyols and proteins including 2.3% non-gluten, 45% gluten , 52% gliadin and

Treatment - Drugs

Placebo

The gluten group is given a packet containing gluten meal (free of fermentable oligo di-monosaccharides and polyols and proteins including 2.3% non-gluten, 45% gluten , 52% gliadin and 27.7 gr glucose

The placebo group is given packets containing powder of gluten-free foods (plain flour, corn starch and glucose). Patients consume powder for 6 weeks, while both groups continue gluten-free diet. Pa

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: The study population consist of having IBS based on Rome III diagnostic criteria . Inclusion criteria for the study subjects are: IBS according to Rome III diagnostic criteria of having; age more than 16 years; with informed consent regarding participation in the research project. Exclusion criteria include patients who do not consent to participate in the study; symptoms of gluten-free diet in the first phase of the study; serum Anti TTG positive test; Celiac disease; Pathologic positive CD (Marsh greater than zero) that in patient who (because of positive tests for each of the HLA-DQ2, HLA-DQ8; anti Gliadin Ab (IgG), (IgA) anti Gliadin Ab) underwent endoscopic duodenal biopsy specimens is taken; inflammatory bowel disease; Depression; diabetes; alcohol abuse; none steroidal anti-inflammatory drugs; abnormal levels of glucose; urea; creatinine; sodium; potassium; hemoglobin; ESR and thyroid functional tests.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Feeling gas in stomach. Timepoint: BeforE intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Abdominal pain. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Defecation satisfaction. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Nausea. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.	—

Measure

Time frame

Feeling gas in stomach. Timepoint: BeforE intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Abdominal pain. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Defecation satisfaction. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.;Nausea. Timepoint: Before intervention, at the end of the first week till 6th week. Method of measurement: VAS.

—

Secondary

Measure	Time frame
Fatigue. Timepoint: Before intervention and at the end of 6th week. Method of measurement: VAS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Saeed Sadeghi

Imam Khomeini Hospital

dr.a_sadeghi@yahoo.com+98 21 6658 1650

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026