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

What Was Tested

This randomized controlled trial paper looks at Larazotide in the context of celiac disease and gluten sensitivity.

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.

Who Took Part

The abstract describes 342 adults taking part.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

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.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Larazotide and who got the comparison, which limits bias.

As a double-blind Larazotide study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Larazotide group a baseline to be compared against.

Running at several centres spread the Larazotide study over different clinics and patient groups.

What Was Measured

The subject headings attached to it are Celiac Disease, Combined Modality Therapy, Diet, Gluten-Free, Gastrointestinal Agents, North America and Oligopeptides.

Author keywords: Therapeutic and Tight Junction.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Larazotide in 342 adults in people with celiac disease and gluten sensitivity.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (Gastroenterology), a journal based in United States.

More context: the Larazotide compound page, Celiac disease and gluten sensitivity research.