Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Brief Summary: The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Options:
A: 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
B: Arm Label: co-transplantation of FMT and pectin; Type: EXPERIMENTAL; Interventions: Other: co-transplantation of FMT and pectin | Arm Label: single fecal microbiota transplantation; Type: ACTIVE_COMPARATOR; Interventions: Other: single fecal microbiota transplantation | Arm Label: give pectin 20g/d; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: pure give pectin 20g/d for five days | Intervention Type: OTHER; Name: co-transplantation of FMT and pectin; Assigned to Arm(s): co-transplantation of FMT and pectin | Intervention Type: OTHER; Name: single fecal microbiota transplantation; Assigned to Arm(s): single fecal microbiota transplantation | Intervention Type: DIETARY_SUPPLEMENT; Name: pure give pectin 20g/d for five days; Assigned to Arm(s): give pectin 20g/d
C: Arm Label: placebo enema; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo enema | Arm Label: Fecal transplant from an unrelated donor; Type: ACTIVE_COMPARATOR; Interventions: Other: Fecal transplant | Intervention Type: OTHER; Name: Fecal transplant; Assigned to Arm(s): Fecal transplant from an unrelated donor | Intervention Type: OTHER; Name: Placebo enema; Assigned to Arm(s): placebo enema
D: Arm Label: faecal transplantation; donor faeces; Type: ACTIVE_COMPARATOR; Interventions: Other: treatment with faecal transplantation (donor faeces) | Arm Label: faecal transplantation; placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: treatment with faecal transplantation (own faeces) | Intervention Type: OTHER; Name: treatment with faecal transplantation (donor faeces); Assigned to Arm(s): faecal transplantation; donor faeces | Intervention Type: OTHER; Name: treatment with faecal transplantation (own faeces); Assigned to Arm(s): faecal transplantation; placebo

Answer: A