Safety Study of Larazotide Acetate to Treat Celiac Disease.

What Was Tested

The trial (phase 1) is built around Larazotide for celiac disease and gluten sensitivity.

It had two arms (groups): Larazotide acetate (experimental) and Placebo (placebo comparator).

Placebo capsules: QD x 3 days.

The registry classes the interventions as drug.

More on the Plan

Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by a 6-hour urine collection.

Sucrose, lactulose, mannitol, zonulin and larazotide acetate concentrations were determined by validated analytical methods.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to people of any sex aged from 18 years up to 59 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report). Subject must be on a gluten-free diet for at least the past 6 months.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: subject has anti-tissue transglutaminase (ttg) \> 10 eu as measured by serology.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the celiac disease and gluten sensitivity participants stayed in one arm throughout.

Blinding on both sides kept the celiac disease and gluten sensitivity participants and researchers unaware of who received Larazotide.

Those kept unaware of assignments: participant and investigator.

It started in 2005-11-29 with completion listed for 2006-01-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Self-reported measures of GI discomfort and Patient Global Assessment of Disease Status.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Larazotide in 21 people with celiac disease and gluten sensitivity.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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