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# Clinical Hold Lifted on Diarrhea Trials
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-diarrhea-trials/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154387

FDA has lifted a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea. The product is designed to target a digestive tract disorder that is commonly caused by Campylobacter and Enterotoxigenic *Escherichia coli* (ETEC), according to the company.

The company says the safety and efficacy of the product will be evaluated in two controlled human clinical trials — one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second focusing on moderate to severe campylobacteriosis.

The FDA hold was placed 7/2022 on the U.S. Naval Medical Research Center (NMRC)-conducted studies, and it indicated that the IND did not contain sufficient information required under 21 CFR 312.23 to assess the risk to subjects in the proposed clinical studies, Immuron said at the time. “The NMRC has previously filed and had IND applications approved by the FDA on similar colostrum-based products without being requested for supporting pharmacology/toxicology data,” the company said.