Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Diarrhea Clinical Trial

Official title:

Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094041
• Other study ID #: 09-007344
• Status: Completed
• Phase: N/A
• First received: March 25, 2010
• Last updated: May 8, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The specific hypotheses are:

Gluten supplementation for four weeks increases small intestinal permeability and accelerates colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.

Description:

The study design is a double-blind, randomized, controlled, parallel-group, 6-week study comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea predominant IBS patients. All participants will keep a daily bowel pattern diary throughout the study. All participants will have negative serum tissue transglutaminase (TTg) assay, and anti-endomysial antibody test, if TTg is positive or equivocal. All participants will have the following studies performed both before and after the 4-week dietary intervention:

1. Stool samples to check markers of inflammation such as fecal calprotectin.

2. Blood samples to check markers of inflammation and for genetic testing.

3. After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability.

4. After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis.

5. Scintigraphy to measure gastrointestinal transit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

1. Diarrhea or diarrhea predominant IBS patients

2. Age 18 to 65

3. BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria

4. No restrictions on Hospital Anxiety Depression score

5. No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion criteria:

1. Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease

2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)

3. Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)

4. Use of oral corticosteroids within the previous 6 weeks

5. Ingestion of artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda

6. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.

7. Any females who are pregnant or trying to become pregnant (due to radiation exposure)

8. Bleeding disorders or medications that increase risk of bleeding from mucosal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease
• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Gluten free diet
A 4-week gluten free diet provided
• Gluten rich diet
A 4-week gluten rich diet is provided

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small bowel permeability	Excretion of mannitol 0-2 hours after liquid formulation	0 - 2 hours post sugar ingestion	No
Primary	Colonic permeability	Cumulative excretion of mannitol at 2-24 hours after liquid	2 -24 hours post sugars ingestion	No
Primary	Colonic transit	Colonic transit geometric center at 24 hours	24 hours	No
Secondary	Colon transit	Ascending colon emptying T1/2	6-12 hours	No
Secondary	Colonic permeability	Cumulative excretion of lactulose	2-24 hours after sugars ingestion	No
Secondary	Colonic permeability	Hourly excretion of mannitol	8 to 24 hours after ingestion of sugars	No
Secondary	Small bowel transit time	Colonic filling at 6 hours (%)	6 hours	No
Secondary	Gastric emptying	Gastric emptying T1/2	0-2 hours	No
Secondary	Colonic inflammatory response	Sigmoid colon mucosal immunocyte count in lamina propria	4 weeks	No
Secondary	Stool frequency and consistency	Bowel pattern diary	6 weeks	No
Secondary	Small bowel inflammatory response	Duodenal mucosal immunocyte count in lamina propria	4 weeks	No