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Study · Randomized controlled trial · n = 86 · 2012

5 results

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

Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA

The American journal of gastroenterology24 Jul 2012Cited by 138 (Europe PMC)

PMID22825365 (opens in a new tab)PMCIDPMC3463856 (opens in a new tab)DOI10.1038/ajg.2012.211 (opens in a new tab)PepBankPUB-22825365
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with celiac disease during gluten challenge, LAMA ratios did not differ significantly between larazotide and placebo.

    In plain wordsIn patients with celiac disease during gluten challenge, larazotide and placebo did not significantly differ in the intestinal permeability measure.

    Peptide
    Larazotide
    Outcome
    No significant changeLactulose/mannitol ratio
    Study

    n: not reported in source

    Comparator
    Placebo during gluten challenge
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.25, 1, 4, or 8 mg three times per day · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Among patients receiving the gluten challenge, the difference in the LAMA ratios for the larazotide acetate and placebo groups was not statistically significant.
    1 context sentence
    Summary · context
    In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with celiac disease, larazotide appeared to limit gluten-induced worsening of gastrointestinal symptom severity on the GSRS at some lower doses but not at the higher dose, versus placebo.

    In plain wordsIn patients with celiac disease, some lower larazotide doses appeared to limit gluten-induced gut symptom worsening, but the higher dose did not, compared with placebo.

    Peptide
    Larazotide
    Outcome
    MixedGastrointestinal symptom worsening on GSRS
    Study

    n: not reported in source

    Comparator
    Placebo during gluten challenge
    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.25, 1, 4, or 8 mg three times per day · 14 daysAs given in this study (human).

    Source sentences

    Summary
    However, larazotide acetate appeared to limit gluten-induced worsening of gastrointestinal symptom severity as measured by the Gastrointestinal Symptom Rating Scale at some lower doses but not at the higher dose.
    1 context sentence
    Summary · context
    In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days.
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with celiac disease, larazotide was generally well tolerated.

    In plain wordsIn patients with celiac disease, larazotide was generally well tolerated.

    Peptide
    Larazotide
    Outcome
    Not applicableTolerability
    Study

    n = 86

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.25, 1, 4, or 8 mg three times per day · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Larazotide acetate was generally well tolerated.
    1 context sentence
    Summary · context
    In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days.
  4. 04HumanRandomized controlled trialSafety outcome

    In the celiac disease trial, no serious adverse events were observed.

    In plain wordsIn the celiac disease trial, no serious adverse events were observed.

    Peptide
    Larazotide
    Outcome
    Not applicableSerious adverse events
    Study

    n = 86

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.25, 1, 4, or 8 mg three times per day · 14 daysAs given in this study (human).

    Source sentences

    Summary
    No serious adverse events were observed.
    1 context sentence
    Summary · context
    In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days.
  5. 05HumanRandomized controlled trialSafety outcome

    In the celiac disease trial, headache and urinary tract infection were the most common adverse events; arm-specific rates were not reported.

    In plain wordsIn the celiac disease trial, headache and urinary tract infection were the most common adverse events, but the abstract did not give rates by treatment.

    Peptide
    Larazotide
    Outcome
    Direction not reportedMost common adverse events (headache, urinary tract infection)
    Study

    n = 86

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.25, 1, 4, or 8 mg three times per day · 14 daysAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events were headache and urinary tract infection.
    1 context sentence
    Summary · context
    In this dose-ranging, placebo-controlled study, 86 patients with celiac disease controlled through diet were randomly assigned to larazotide acetate (0.25, 1, 4, or 8 mg) or placebo three times per day with or without gluten challenge (2.4 g/day) for 14 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00362856

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

9 Meters Biopharma, Inc.n = 8013 Sept 2006 to 6 Mar 2007

Celiac Disease

Trial pageClinicalTrials.govUpdated 12 Sept 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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