Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route
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|ClinicalTrials.gov Identifier: NCT02449174|
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|C. Difficile||Biological: Frozen Microbiota Biological: Lyophilized Microbiota||Phase 1 Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Allocation: Randomized Endpoints: Safety, preliminary efficacy in preventing future bouts of CDAD and improvement in intestinal flora diversity Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||frozen intestinal bacteria from a healthy donor given by retention enema or lyophilized intestinal bacteria given orally in capsules for therapy in subjects with recurrent C. difficile associated diarrhea (RCDAD)|
|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|
|Actual Study Start Date :||March 17, 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2018|
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 Microbiota 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.
- Safety as Assessed by Number of Participants With Any Adverse Events (AE)s [ Time Frame: 6 months after the procedure ]any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
- Number of Participants Who Continue to Have Diarrhea and C. Difficile Toxin Following Fecal Microbiota Transplantation From a Healthy Donor [ Time Frame: 60 days after the procedure ]diarrhea was defined as more than 3 episodes of loose/watery stools in 2 consecutive days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449174
|United States, Texas|
|University of Texas Health Science Center at Housotn|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Herbert l DuPont, MD||University of Texas School of Public Health|