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Trial protocolGut health

BPC-157 80 mg enema, the Croatian ulcerative colitis trial

Reduce disease activity in mild to moderate ulcerative colitis

The schedule a registered trial actually ran, taken from the paper and the trial registration rather than from a label summary. Every one carries a PubMed or ClinicalTrials record you can open.

Not advice. This is a record of a schedule, not a dose for you.

The schedule, as reported

Each field below is what the source states, not a rounded version of it. Where the source does not publish a detail, the field says so instead of filling the gap.

Amount
80 mg
Frequency
Once daily
Route
Rectal enema
Duration
Two weeks

What was measured

Change in the Disease Activity Index across two weeks. Nothing about tendon, ligament, joint or muscle healing was measured, because this was a bowel trial.

What was reported

Results as the trial reported them, with their comparators.

  • 53 adults with mild to moderate ulcerative colitis were randomised and 46 completed.

  • Mean Disease Activity Index change was -3.2 (95 percent CI -5.58 to -0.82) on BPC-157 and -1.6 (95 percent CI -3.86 to 0.67) on placebo.

  • The estimated between group difference was 1.6 points and its confidence interval crossed zero (95 percent CI -4.84 to 1.62), so the result is compatible with no effect.

  • Three subjects on BPC-157 and two on placebo withdrew for adverse events, mainly worsening colitis.

Where this comes from

Ruenzi et al. 2005, a multicentre randomised double blind trial run by Pliva in Croatia under the code PL 14736, reported as a meeting abstract and inventoried in FDA's CDER evaluation of BPC-157 bulk drug substances dated 11 May 2026.

This is the only randomised placebo controlled trial of BPC-157 in people. It was never published as a full paper, so the numbers above come from FDA's own inventory of the abstract. The PubMed record below is a 2012 review from the Zagreb group that developed the peptide, and it confirms PL 14736 had reached clinical phase II for inflammatory bowel disease and no further.

What this protocol cannot tell you

Required on every entry in this registry, and never empty.

The one randomised trial of BPC-157 in humans did not separate from placebo. It tested a rectal enema at 80 mg for ulcerative colitis, which is not the route, the dose, the indication or the duration that anybody buying BPC-157 for a tendon is using. It was never published in full, so what is recorded here is an FDA reviewer's account of a meeting abstract rather than a report anyone can read. No trial has ever dosed BPC-157 subcutaneously for an injury and reported a result: the first one, a 120 person phase 2 in hamstring strain, began recruiting in February 2026 and expects primary completion in February 2027.

The compounds in this protocol

Each profile carries the full evidence record, the legal status and what the trials did not show.

  • BPC-157

    A pentadecapeptide with a large animal literature on tendon, ligament, muscle and gut healing, and a small human record: two rectal-enema studies run in Croatia, three uncontrolled clinic reports, and a randomized Phase 2 injury trial now recruiting.

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