A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Teslanbaicin in Patients With Radiation Proctitis

"Patients clinically diagnosed with radiation proctitis of CTCAE grade I-II will receive oral administration. Three dose groups of Teslanbai bacteria are tentatively planned, formulated as capsules with viable bacterial counts per capsule of ≥1107 CFU, 1108 CFU, and 1\*109 CFU, respectively. A 3+3 dose-escalation design will be adopted. Each dose group will enroll 3 subjects. If 1 subject experiences a grade ≥3 adverse reaction, 3 additional patients will be added. If 2 subjects exhibit adverse reactions, enrollment into higher dose groups will be discontinued. The final dosage for subsequent use of Teslanbai bacteria will be determined based on efficacy and safety data.~Approximately 9 subjects are planned for enrollment. After determining the optimal dosage, investigators and sponsors will decide whether to proceed to Phase II based on the study results and external data."

A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis