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Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Primary Purpose

Diarrhea, Diarrhea Predominant Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gluten free diet

Gluten rich diet

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Gluten, Diarrhea or diarrhea predominant irritable bowel syndrome, Colonic permeability, Small bowel permeability, Colonic inflammatory response, Small bowel inflammatory response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Diarrhea or diarrhea predominant IBS patients
Age 18 to 65
BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria
No restrictions on Hospital Anxiety Depression score
No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion criteria:

Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease
Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
Use of oral corticosteroids within the previous 6 weeks
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
Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.
Any females who are pregnant or trying to become pregnant (due to radiation exposure)
Bleeding disorders or medications that increase risk of bleeding from mucosal

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Gluten free diet

Gluten rich diet

Arm Description

Outcomes

Primary Outcome Measures

Small bowel permeability

Excretion of mannitol 0-2 hours after liquid formulation

Colonic permeability

Cumulative excretion of mannitol at 2-24 hours after liquid

Colonic transit

Colonic transit geometric center at 24 hours

Secondary Outcome Measures

Colon transit

Ascending colon emptying T1/2

Colonic permeability

Cumulative excretion of lactulose

Colonic permeability

Hourly excretion of mannitol

Small bowel transit time

Colonic filling at 6 hours (%)

Gastric emptying

Gastric emptying T1/2

Colonic inflammatory response

Sigmoid colon mucosal immunocyte count in lamina propria

Stool frequency and consistency

Bowel pattern diary

Small bowel inflammatory response

Duodenal mucosal immunocyte count in lamina propria

Full Information

NCT ID

NCT01094041

First Posted

March 25, 2010

Last Updated

May 8, 2013

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01094041

Brief Title

Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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: Stool samples to check markers of inflammation such as fecal calprotectin. Blood samples to check markers of inflammation and for genetic testing. After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability. After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis. Scintigraphy to measure gastrointestinal transit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea, Diarrhea Predominant Irritable Bowel Syndrome

Keywords

Gluten, Diarrhea or diarrhea predominant irritable bowel syndrome, Colonic permeability, Small bowel permeability, Colonic inflammatory response, Small bowel inflammatory response

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gluten free diet

Arm Type

Experimental

Arm Title

Gluten rich diet

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Gluten free diet

Intervention Description

A 4-week gluten free diet provided

Intervention Type

Other

Intervention Name(s)

Gluten rich diet

Intervention Description

A 4-week gluten rich diet is provided

Primary Outcome Measure Information:

Title

Small bowel permeability

Description

Excretion of mannitol 0-2 hours after liquid formulation

Time Frame

0 - 2 hours post sugar ingestion

Title

Colonic permeability

Description

Cumulative excretion of mannitol at 2-24 hours after liquid

Time Frame

2 -24 hours post sugars ingestion

Title

Colonic transit

Description

Colonic transit geometric center at 24 hours

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Colon transit

Description

Ascending colon emptying T1/2

Time Frame

6-12 hours

Title

Colonic permeability

Description

Cumulative excretion of lactulose

Time Frame

2-24 hours after sugars ingestion

Title

Colonic permeability

Description

Hourly excretion of mannitol

Time Frame

8 to 24 hours after ingestion of sugars

Title

Small bowel transit time

Description

Colonic filling at 6 hours (%)

Time Frame

6 hours

Title

Gastric emptying

Description

Gastric emptying T1/2

Time Frame

0-2 hours

Title

Colonic inflammatory response

Description

Sigmoid colon mucosal immunocyte count in lamina propria

Time Frame

4 weeks

Title

Stool frequency and consistency

Description

Bowel pattern diary

Time Frame

6 weeks

Title

Small bowel inflammatory response

Description

Duodenal mucosal immunocyte count in lamina propria

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diarrhea or diarrhea predominant IBS patients Age 18 to 65 BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria No restrictions on Hospital Anxiety Depression score No abdominal surgery (except appendectomy and cholecystectomy) Exclusion criteria: Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability) Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability) Use of oral corticosteroids within the previous 6 weeks 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 Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins. Any females who are pregnant or trying to become pregnant (due to radiation exposure) Bleeding disorders or medications that increase risk of bleeding from mucosal

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Camilleri, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23357715

Citation

Vazquez-Roque MI, Camilleri M, Smyrk T, Murray JA, Marietta E, O'Neill J, Carlson P, Lamsam J, Janzow D, Eckert D, Burton D, Zinsmeister AR. A controlled trial of gluten-free diet in patients with irritable bowel syndrome-diarrhea: effects on bowel frequency and intestinal function. Gastroenterology. 2013 May;144(5):903-911.e3. doi: 10.1053/j.gastro.2013.01.049. Epub 2013 Jan 25.

Results Reference

derived

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Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

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