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Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094041
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : May 10, 2013
Sponsor:
Information provided by:
Mayo Clinic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diarrhea Diarrhea Predominant Irritable Bowel Syndrome Other: Gluten free diet Other: Gluten rich diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Small bowel permeability [ Time Frame: 0 - 2 hours post sugar ingestion ]
    Excretion of mannitol 0-2 hours after liquid formulation

  2. Colonic permeability [ Time Frame: 2 -24 hours post sugars ingestion ]
    Cumulative excretion of mannitol at 2-24 hours after liquid

  3. Colonic transit [ Time Frame: 24 hours ]
    Colonic transit geometric center at 24 hours


Secondary Outcome Measures :
  1. Colon transit [ Time Frame: 6-12 hours ]
    Ascending colon emptying T1/2

  2. Colonic permeability [ Time Frame: 2-24 hours after sugars ingestion ]
    Cumulative excretion of lactulose

  3. Colonic permeability [ Time Frame: 8 to 24 hours after ingestion of sugars ]
    Hourly excretion of mannitol

  4. Small bowel transit time [ Time Frame: 6 hours ]
    Colonic filling at 6 hours (%)

  5. Gastric emptying [ Time Frame: 0-2 hours ]
    Gastric emptying T1/2

  6. Colonic inflammatory response [ Time Frame: 4 weeks ]
    Sigmoid colon mucosal immunocyte count in lamina propria

  7. Stool frequency and consistency [ Time Frame: 6 weeks ]
    Bowel pattern diary

  8. Small bowel inflammatory response [ Time Frame: 4 weeks ]
    Duodenal mucosal immunocyte count in lamina propria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094041


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Camilleri, MD Mayo Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01094041    
Other Study ID Numbers: 09-007344
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013
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:
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Irritable Bowel Syndrome
Celiac Disease
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Metabolic Diseases