Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Study of Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent C. Difficile Associated Diarrhea (RCDAD) Via Retention Enema or Oral Route
Brief Summary: The objective of the study is to investigate the safety of a frozen or lyophilized inoculum administered, respectively, by retention enema or capsules in patients with recurrent C. difficile associated diarrhea (RCDAD).

This is a single center, randomized, parallel assignment, open label safety study conducted in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1 ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized donor intestinal bacteria. All subjects will be followed for a total of 3 years after study completion.

Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases at University of Texas School of Public Health (UT-SPH). The donors will come from a variety of places, including the UT-SPH. At least 20 donors will be screened to recruit at least 15 qualified donors.

Recipients may self-refer but must have a physician who agrees to accept care of the patient following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's care will be returned to their physician. At least 75 recipients will be screened to recruit 50 qualified recipients.

The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with secondary endpoint related to efficacy prevention of RCDAD. In order to monitor any health effects for safety, participants will be contacted pre- and 7, 14, 30 days, then monthly basis for the first 90 days after FMT and quarterly till 3 years after FMT. The following procedures will be completed: review recipient diary with the recipient to ensure that the following information is recorded correctly and a fresh stool sample will be collected from recipient, tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome analysis. Recipients will be contacted by phone for their diarrhea status on monthly basis till 90 days after FMT, then on quarterly basis till 3 years after FMT.


Options:
A: Arm Label: Frozen Microbiota; Type: ACTIVE_COMPARATOR; Interventions: Biological: Frozen Microbiota | Arm Label: Lyophilized Microbiota; Type: ACTIVE_COMPARATOR; Interventions: Biological: Lyophilized Microbiota | Intervention Type: BIOLOGICAL; Name: Frozen Microbiota; Assigned to Arm(s): Frozen Microbiota | Intervention Type: BIOLOGICAL; Name: Lyophilized Microbiota; Assigned to Arm(s): Lyophilized Microbiota
B: Arm Label: Fecal transplantation; Type: EXPERIMENTAL; Interventions: Biological: Fecal transplantation | Arm Label: Placebo fecal transplantation; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo fecal transplant | Intervention Type: BIOLOGICAL; Name: Fecal transplantation; Assigned to Arm(s): Fecal transplantation | Intervention Type: OTHER; Name: Placebo fecal transplant; Assigned to Arm(s): Placebo fecal transplantation
C: Arm Label: Multiple-infusion FMT; Type: EXPERIMENTAL; Interventions: Drug: Vancomycin (before randomization), Biological: multiple-infusion FMT | Arm Label: Single-infusion FMT; Type: ACTIVE_COMPARATOR; Interventions: Biological: Single-infusion FMT, Drug: Vancomycin (before randomization) | Intervention Type: BIOLOGICAL; Name: Single-infusion FMT; Assigned to Arm(s): Single-infusion FMT | Intervention Type: DRUG; Name: Vancomycin (before randomization); Assigned to Arm(s): Multiple-infusion FMT, Single-infusion FMT | Intervention Type: BIOLOGICAL; Name: multiple-infusion FMT; Assigned to Arm(s): Multiple-infusion FMT
D: Arm Label: Fecal Microbiota Transplantation; Type: ACTIVE_COMPARATOR; Interventions: Biological: Fecal Microbiota Transplantation | Arm Label: Sham Fecal Microbiota Transplantation; Type: SHAM_COMPARATOR; Interventions: Biological: Sham Fecal Microbiota Transplantation | Intervention Type: BIOLOGICAL; Name: Fecal Microbiota Transplantation; Assigned to Arm(s): Fecal Microbiota Transplantation | Intervention Type: BIOLOGICAL; Name: Sham Fecal Microbiota Transplantation; Assigned to Arm(s): Sham Fecal Microbiota Transplantation

Answer: A