Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum
Brief Summary: Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope.

Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either:

* colonoscopy
* NGT

The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.


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: Fresh FMT; Type: EXPERIMENTAL; Interventions: Biological: Fresh FMT | Arm Label: Frozen-and-Thawed FMT; Type: EXPERIMENTAL; Interventions: Biological: Frozen-and-Thawed FMT | Intervention Type: BIOLOGICAL; Name: Fresh FMT; Assigned to Arm(s): Fresh FMT | Intervention Type: BIOLOGICAL; Name: Frozen-and-Thawed FMT; Assigned to Arm(s): Frozen-and-Thawed FMT
C: Arm Label: Delivery via capsule; Type: EXPERIMENTAL; Interventions: Biological: Fecal Microbiota Transplant | Arm Label: Delivery via colonoscopy; Type: EXPERIMENTAL; Interventions: Biological: Fecal Microbiota Transplant | Intervention Type: BIOLOGICAL; Name: Fecal Microbiota Transplant; Assigned to Arm(s): Delivery via capsule, Delivery via colonoscopy
D: Arm Label: Colonoscopy; Type: EXPERIMENTAL; Interventions: Drug: Fecal Microbiota Transplant (FMT) | Arm Label: Nasogastric Tube (NGT); Type: EXPERIMENTAL; Interventions: Drug: Fecal Microbiota Transplant (FMT) | Intervention Type: DRUG; Name: Fecal Microbiota Transplant (FMT); Assigned to Arm(s): Colonoscopy, Nasogastric Tube (NGT)

Answer: D