A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge

What Was Tested

The paper reports a study of Larazotide in the context of celiac disease and gluten sensitivity, published as a randomized controlled trial.

In patients with celiac disease, enteropathy is caused by the entry of gluten peptides into the lamina propria of the intestine, in which their immunogenicity is potentiated by tissue transglutaminase (tTG) and T-helper type 1-mediated immune responses are triggered.

Tight junction disassembly and paracellular permeability are believed to have an important role in the transport of gluten peptides to the lamina propria.

Who Took Part

The study group was 86 patients.

PubMed indexes the participants as adults and middle-aged adults, both men and women.

How the Study Was Run

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

Because people in this Larazotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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.

Secondary endpoints included gastrointestinal symptom severity, quality-of-life measures, and antibodies to tTG.

What Was Measured

The subject headings attached to it are Acute Disease, Celiac Disease, Gastrointestinal Agents, Glutens, Oligopeptides, Secondary Prevention and Tight Junctions.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Larazotide in 86 patients in people with celiac disease and gluten sensitivity.

Results are reported in around 10 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2012 (The American journal of gastroenterology), a journal based in United States.

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