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FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

However, this amount can increase for those with B12 absorption issues, pregnant or breastfeeding women, and others with increased physiological needs

A thorough evaluation should include sleep study results if available, hormone level testing, and discussion of potential interactions with existing treatments

JAMA 329, 214223