Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study

What Was Tested

This randomized controlled trial paper looks at Larazotide.

Coeliac disease, an autoimmune disorder triggered by gluten ingestion, is managed by a gluten-free diet (GFD), which is difficult for many patients.

Who Took Part

The study group was 184 patients.

The age groups tagged for this paper are young adults, adults and middle-aged adults, both men and women.

This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.

Outcomes included an experimental biomarker of intestinal permeability, the lactulose-to-mannitol (LAMA) ratio and clinical symptoms assessed by Gastrointestinal Symptom Rating Scale (GSRS) and anti-transglutaminase antibody levels.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

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

Blinding on both sides kept the patients and researchers unaware of who received Larazotide.

The comparison arm used a placebo, so changes seen with Larazotide could be set against what happens without it.

What Was Measured

The subject headings attached to it are Autoantibodies, Celiac Disease, Diet, Gluten-Free, Gastrointestinal Agents, Glutens, Lactulose and Oligopeptides.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Larazotide in 184 patients.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (Alimentary pharmacology & therapeutics), a journal based in England.

More context: the Larazotide compound page, all human trials.