Trial record 7 of 15 for:    gluten | Open Studies | United States

Change in Permeability of the Small Intestine After Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Maria I. Vazquez Roque, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02098057
First received: March 14, 2014
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).


Condition Intervention
Gastrointestinal Disorders
Dietary Supplement: Gluten Healthy
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in permeability of the small intestine after treatment [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
Drug: Placebo

A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio

Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.

Active Comparator: Gluten
A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
Dietary Supplement: Gluten Healthy
Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.

Detailed Description:

The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non celiac gluten sensitive patients with a functional bowel disorder
  2. Age 18 to 70 years.

Exclusion Criteria:

  1. Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) 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. Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation)
  4. Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability).
  5. Use of oral corticosteroids within the previous 6 weeks.
  6. Ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda.
  7. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
  8. High anxiety or depression score (>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire.
  9. Known allergy to fluorescein.
  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: NCT02098057

Contacts
Contact: Jonathan J Wright, MHSc, CCRP 904 953 7521 wright.jonathan@mayo.edu
Contact: Verna A Skinner, MSBh, CCRP 904 953 8982 skinner.verna@mayo.edu

Locations
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jonathan J Wright, MHSc, CCRP    904-953-7521    wright.jonathan@mayo.edu   
Principal Investigator: Maria Vazquez Roque, MD,MSc         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Maria Vazquez Roque, MD, MSc Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Maria I. Vazquez Roque, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02098057     History of Changes
Other Study ID Numbers: 13-005160, FP00074933
Study First Received: March 14, 2014
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
IBS-diarrhea

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 20, 2014