Does the Donor Matter? Donor vs Patient Effects in the Outcome of a Next Generation Microbiota-based Drug Trial for Recurrent Clostridium difficile Infection

Arnab Ray1,Courtney Jones2

1Ochsner Clinic Foundation, New Orleans, Lousiana; 2Rebiotix Inc., Roseville, Minnesota.

Does the Donor Matter in Fecal Microbiota Therapy for Recurrent Clostridium difficile Infection

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View the abstract PubMed

Future Medicine (2016): doi:10.2217/fmb.16.10
Published online March 17, 2016

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).

Conclusions

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

Keywords: Clostridium difficile infection, fecal microbiota transplant, fecal transplantation, FMT, FT, gut microbiota, RBX2660, stool donor.