InfoTiming Sensitive
Probiotics
Probiotics can alter GI symptoms and make it harder to judge larazotide response.
Recommendation: Change one gut intervention at a time under clinician guidance.
Larazotide Acetate
Peptide ·Emerging evidence ·Reviewed May 2026
Larazotide acetate is an oral octapeptide zonulin-pathway antagonist investigated as an adjunct for celiac disease symptoms despite a gluten-free diet. It is not FDA-approved, and its phase 3 celiac disease program was discontinued after interim analysis did not support trial continuation. Earlier phase 2 signals make it biologically interesting, but it is not an approved leaky-gut or gluten-exposure treatment.
What it's good for
The bottom line
Evidence rating emerging. Most-documented uses: investigated for persistent celiac symptoms, designed to reduce tight-junction permeability, oral local gut peptide. 3 sources indexed (2013–2022), with 3 interaction records on file.
The science
How it works, mechanistically.
Core mechanism
Larazotide is designed to act locally in the gut lumen to reduce zonulin-mediated tight-junction opening and intestinal permeability after gluten exposure. The intended effect is barrier modulation rather than immune tolerance or gluten digestion. It does not permit gluten ingestion in celiac disease and does not replace a strict gluten-free diet.1,2
Class
Investigational intestinal tight-junction regulator
Found in food
None as a dietary supplement
Low-status signs
No recognized dietary deficiency state exists for this peptide
Absorption
Best on an empty stomach
Dosing
Dosing & protocol.
Common range
Clinical trials commonly studied 0.5 mg three times daily before meals; no approved dose exists
Recommended form
Investigational oral capsule only in clinical research
Trials administered larazotide before meals to act locally in the intestinal lumen. It is not a dietary supplement and should not be used to permit gluten exposure.1
Forms
Forms & what to buy.
Ranked by evidence and value.
Investigational Oral Larazotide Capsule Recommended
Designed for local intestinal action with limited systemic exposure. Taken before meals in trials.
Compounded or Research Larazotide
Quality and legality vary and efficacy is unproven. Unregulated products may be mislabeled.
Cost
What it actually costs.
Real-world pricing across three quality tiers. Assumes Investigational Oral Larazotide Capsule.
BudgetBest value
$60 /mo
$2.00 per dose
Mid
$180 /mo
$6.00 per dose
Premium
$450 /mo
$15.00 per dose
Research-market pricing is not a dosing recommendation; human use is not FDA-approved unless specifically stated. Updated 2026-06-04.
Goals
Goal-based dosing.
Persistent Celiac Symptoms
Dose: No FDA-approved dose; trials studied 0.5 mg three times daily before meals1,2
Timing: Before meals in trials
Not approved and phase 3 was discontinued.
Gluten Exposure Protection
Timing: Not applicable
Does not replace gluten-free diet.
Leaky Gut Wellness
Dose: No approved dose
Timing: Not applicable
Leaky-gut marketing claims exceed evidence.
Lab work
Markers to track.
What to test, the optimal window inside the conventional range, and how long a response takes.
Tissue Transglutaminase IgA Antibody tTG-IgA
Larazotide is not proven to normalize celiac serologies; use for celiac monitoring under care.1,2
Optimal
0–20 U/mL
Conventional
0–20 U/mL
Responds in
Per gastroenterology plan
0optimal20
Negative serology does not always prove mucosal healing.
Total IgADeamidated gliadin peptide antibodies
Why people use it
Symptoms it's matched to.
Where this appears in the symptom-to-supplement map, ranked by relevance.
Bloating after gluten exposure
22% relevance
Designed to reduce tight-junction opening in celiac research, but not approved.1,2
DigestiveEmerging evidenceInvestigational oral capsule
Strict gluten avoidance remains standard for celiac disease.
Diarrhea
14% relevance
Persistent celiac GI symptoms were a trial target, but diarrhea has many causes.1,2
DigestiveEmerging evidenceClinical research only
Evaluate infection, IBD, lactose, FODMAP, and gluten contamination.
Abdominal pain
12% relevance
Symptom improvement was studied in celiac disease populations only.1,2
PainEmerging evidenceClinical research only
Severe pain needs medical evaluation.
Safety
Full safety detail.
Side effects
- Nausea
- Abdominal discomfort
- Headache
- Diarrhea or constipation
- Failure to control celiac inflammation if used instead of gluten avoidance
Contraindications
Interactions
Interaction records.
ModerateTiming Sensitive
Psyllium Husk
Psyllium can change stool form and may bind or delay orally administered products.
Recommendation: Separate by at least 2 hours in any clinician-supervised protocol.
InfoCaution
Quercetin
Quercetin is often used for barrier or mast-cell claims and can confound symptom tracking.
Recommendation: Avoid unsupported multi-agent leaky-gut stacks.
Sources
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Randomized controlled trials
2- 1Larazotide Acetate for Persistent Symptoms of Celiac Disease Despite a Gluten-Free Diet: A Randomized Controlled TrialNeeds sourceNo linkLeffler DA et al. · Gastroenterology · 2015
0.5 mg dose improved symptom endpoint
- 2Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled studyNeeds sourceNo linkKelly CP et al. · Alimentary Pharmacology and Therapeutics · 2013
Studied as adjunct during controlled challenge
Reference material
1- 39 Meters Biopharma Announces Interim Analysis of Phase 3 Study of Larazotide for Celiac Disease Does Not Support Trial ContinuationNeeds sourceNo link9 Meters Biopharma · Company Press Release · 2022
CedLara phase 3 did not continue after interim analysis
Keep exploring
Deep dives & adjacent profiles.
This page is educational. Do not start, stop, or change a supplement or medication based on it without checking with a qualified healthcare professional.
Use this with your stack
Larazotide Acetate in NutriStack.
Add it to your stack, see how it interacts with everything else you take, and get a Stack Score that updates the moment it does.