The Pep Edit Newsletter

Cheat sheet

Status: Investigational Reviewed

Larazotide

One of the few names people ask us about that actually has multiple human trials, mostly around celiac disease and intestinal permeability.

The evidence rail

How to read this
  1. Mechanistic: reached
  2. Cell research: reached
  3. Animal research: reached
  4. Human observational: reached
  5. Human clinical trial: reached
  6. Established clinical use: not reached
Evidence
Human clinical trialsRung 5 of 6. A designed trial in people with a comparison group. The bar for a real claim.
Status
InvestigationalBeing studied in registered human trials. Not approved.

Why people are talking about it

Leaky gut is one of the biggest conversations in gut health, and larazotide is one of very few compounds that was actually tested in people for intestinal permeability.

What has it been studied for?

  • Tight junctions and gluten-related gut injury in human trials
  • Celiac-adjacent questions, not a general “gut peptide” slogan

What we know

  • Human trial data exists. That is rarer than the feed makes it sound
  • Its largest trial, a Phase 3 in celiac disease, was stopped early in 2022 after an interim analysis found it unlikely to succeed. That is a human result too

What we don’t

  • Whether the earlier, smaller trial results generalize to every gut complaint people map onto it online

What is known about safety

  • In its published randomized trials, side effects were generally similar to placebo. Headache and urinary tract infection were the most common reported in one
  • Those trials lasted weeks to a few months, so longer-term safety is not known
  • It is not approved and is not available as a medicine outside clinical trials

Bottom line

This is a map of the evidence, not a recommendation.

Education only. Not medical advice. Not a protocol.

Sources

  1. Human trial, 342 people, placebo-controlledLarazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial (opens in a new tab)Leffler and colleagues, Gastroenterology, 2015
  2. Human trial, 86 people, placebo-controlledA randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge (opens in a new tab)Leffler and colleagues, American Journal of Gastroenterology, 2012
  3. Phase 3 human trial registryStudy to evaluate the efficacy and safety of larazotide acetate for the relief of celiac disease symptoms (NCT03569007) (opens in a new tab)ClinicalTrials.gov registry entry, status terminated by sponsor

We link to the paper, the trial registry, or the regulator, never to a seller. A study type in the label tells you who or what was actually studied.

Spotted an error or a newer study? Tell the editors. Corrections are noted on the page. Our standards.

Keep reading

  • KPV

    A fragment of alpha-MSH studied for inflammation and skin. Research so far is in cells and animals.

    Evidence: Animal research. Reached rung 3 of 6, Animal research.Not FDA-approved
    InflammationGut healthSkin + hair
    Inflammation

  • BPC-157

    Widely discussed for gut and recovery. The animal literature is large. Human clinical evidence is still thin.

    Evidence: Limited human data. Reached rung 4 of 6, Human observational, with limited data.Not FDA-approved
    Gut healthRecoveryInflammation
    Gut / Recovery

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One email a month. The study type named, every time.