Change in Permeability of the Small Intestine After Treatment With Gluten

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

September 19, 2016

Study Completion Date

September 19, 2016

Conditions
Gastrointestinal Disorders
Interventions
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.

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."

Trial Locations (1)

32224

Mayo Clinic, Jacksonville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER