Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

ABSTRACT:

Background & aims

Celiac disease (CeD) is a prevalent autoimmune condition. Recurrent signs and symptoms are common despite treatment with a gluten-free diet (GFD), yet no approved or proven nondietary treatment is available.

Methods

In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study. The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase. The primary end point was the difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score.

Results

The primary end point was

SUBMITTER: Leffler DA 

PROVIDER: S-EPMC4446229 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature