Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01094041
First received: March 25, 2010
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Diarrhea
Diarrhea Predominant Irritable Bowel Syndrome
Other: Gluten free diet
Other: Gluten rich diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Small bowel permeability [ Time Frame: 0 - 2 hours post sugar ingestion ] [ Designated as safety issue: No ]
    Excretion of mannitol 0-2 hours after liquid formulation

  • Colonic permeability [ Time Frame: 2 -24 hours post sugars ingestion ] [ Designated as safety issue: No ]
    Cumulative excretion of mannitol at 2-24 hours after liquid

  • Colonic transit [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Colonic transit geometric center at 24 hours


Secondary Outcome Measures:
  • Colon transit [ Time Frame: 6-12 hours ] [ Designated as safety issue: No ]
    Ascending colon emptying T1/2

  • Colonic permeability [ Time Frame: 2-24 hours after sugars ingestion ] [ Designated as safety issue: No ]
    Cumulative excretion of lactulose

  • Colonic permeability [ Time Frame: 8 to 24 hours after ingestion of sugars ] [ Designated as safety issue: No ]
    Hourly excretion of mannitol

  • Small bowel transit time [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Colonic filling at 6 hours (%)

  • Gastric emptying [ Time Frame: 0-2 hours ] [ Designated as safety issue: No ]
    Gastric emptying T1/2

  • Colonic inflammatory response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Sigmoid colon mucosal immunocyte count in lamina propria

  • Stool frequency and consistency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Bowel pattern diary

  • Small bowel inflammatory response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Duodenal mucosal immunocyte count in lamina propria


Enrollment: 50
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gluten free diet Other: Gluten free diet
A 4-week gluten free diet provided
Experimental: Gluten rich diet Other: Gluten rich diet
A 4-week gluten rich diet is provided

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094041

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01094041     History of Changes
Other Study ID Numbers: 09-007344
Study First Received: March 25, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Gluten
Diarrhea or diarrhea predominant irritable bowel syndrome
Colonic permeability
Small bowel permeability
Colonic inflammatory response
Small bowel inflammatory response

Additional relevant MeSH terms:
Celiac Disease
Diarrhea
Irritable Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases

ClinicalTrials.gov processed this record on July 29, 2014