Does the donor matter? Donor vs patient effects in the outcome of a next-generation microbiota-based drug trial for recurrent Clostridium difficile infection.

AIM: To evaluate the impact of the donor material versus the patient in outcomes achieved with RBX2660, a microbiota-based drug under study for recurrent Clostridium difficile infection (CDI).

METHODS: RBX2660 was administered to patients enrolled in the previously reported Phase II PUNCH CD study under Rebiotix's Investigational New Drug submission to the US FDA. Four donors were used to prepare the RBX2660 drug product used in the study. The product was manufactured in individual, donor-specific batches that could be tracked to individual patients and their outcomes. Donor products were randomized to patients for both first and second doses.

RESULTS: The individual donor or donor dose order did not significantly affect the outcome of RBX2660 treatment in 34 patients (mean age 68.8 years).

CONCLUSION: The specific donor did not affect the outcomes achieved with administration of RBX2660 for recurrent CDI.