Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route
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. We will screen at least 20 donors 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. We will screen at least 75 recipients 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.
|C. Difficile||Biological: Frozen Microbiota Biological: Lyophilized Microbiota||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study of Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent C. Difficile Associated Diarrhea (RCDAD) Via Retention Enema or Oral Route|
- Number of participants who continue to have diarrhea and C. difficile toxin following fecal microbiota transplantation from a healthy donor [ Time Frame: 3 years after the procedure ]
- Number of participants who develop obesity following fecal microbiota transplantation from a healthy donor [ Time Frame: 3 years after the procedure ]
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Frozen Microbiota
Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Biological: Frozen Microbiota
Frozen Mcirobiota will be delivered via enema route.
Active Comparator: Lyophilized Microbiota
Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Biological: Lyophilized Microbiota
Lyophilized Microbiota will be delivered orally.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02449174
|Contact: Sheri Allred, BSfirstname.lastname@example.org|
|Contact: Zhi-Dong Jiang, MD, Dr.PHemail@example.com|
|United States, Texas|
|University of Texas Health Science Center at Housotn||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sheri L Allred, BS 832-355-4122 firstname.lastname@example.org|
|Contact: Zhi-Dong Jiang, MD, Dr.PH 7135009371 email@example.com|
|Principal Investigator: Herbert L DuPont, MD|
|Sub-Investigator: Zhi-Dong Jiang, MD, DrPH|
|Principal Investigator:||Herbert l DuPont, MD||University of Texas School of Public Health|