Gut barrier / inflammation

Larazotide

An orally administered octapeptide that acts as a tight-junction regulator (zonulin antagonist) to reduce intestinal permeability. The most clinically advanced of the 'leaky gut' peptides, studied in controlled celiac-disease trials, though it has not gained approval.

Awaiting medical review · community notes open

Common doses

IndicationRouteDoseDurationEvidence
Celiac disease (persistent symptoms despite gluten-free diet) — clinical trialsOralStudied around 0.5 mg three times daily in trialsTrial-definedTier 3
Intestinal permeability / 'leaky gut' (off-label, experimental)OralNo established consumer doseExperimentalTier 5

Ask about Larazotide

Get an answer from our reviewed articles and community reports, with links to the sources. Not medical advice.

Limitations · Who should NOT use this

Despite being the most studied gut-barrier peptide, larazotide is not approved: a phase 2b trial showed promise for celiac symptoms, but a later pivotal phase 3 trial did not meet its primary endpoint, and development has been uncertain. 'Leaky gut' as a standalone consumer indication is not well-defined clinically. Trial dosing does not translate directly to self-directed gray-market use. Best understood as an investigational adjunct studied in a specific disease, not a validated general gut-health supplement.

Regulatory notes

Not FDA-approved. The most clinically advanced gut-barrier peptide — studied in randomized controlled trials for celiac disease (including a phase 2b trial), though a pivotal phase 3 did not meet its primary endpoint. Investigational; not available as an approved product.

Sources

  1. Leffler DA, et al. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology 2015;148(7):1311-1319.
  2. Khaleghi S, et al. The potential utility of tight junction regulation in celiac disease: focus on larazotide acetate. Therap Adv Gastroenterol 2016;9(1):37-49.
  3. Paterson BM, et al. The safety, tolerance, pharmacokinetic and pharmacodynamic effects of AT-1001 in celiac disease. Aliment Pharmacol Ther 2007.

More on Larazotide

Community signal — Larazotide

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Community experiences

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Community Notes

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