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Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route

This study is currently recruiting participants.
Verified November 2016 by Zhi-Dong Jiang, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT02449174
First Posted: May 20, 2015
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhi-Dong Jiang, The University of Texas Health Science Center, Houston
  Purpose

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.


Condition Intervention Phase
C. Difficile Biological: Frozen Microbiota Biological: Lyophilized Microbiota Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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

Resource links provided by NLM:


Further study details as provided by Zhi-Dong Jiang, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of participants who develop obesity following fecal microbiota transplantation from a healthy donor [ Time Frame: 3 years after the procedure ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects 18 years of age or older
  2. Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
  3. Required to sign an informed consent form
  4. Subject‟s attending physician agrees to provide care following FMT
  5. Able to follow study procedures and follow-ups.
  6. Diagnosed by medical history of ≥ 3 RCDAD bouts in outpatients or ≥ 2 bouts of RCDAD in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
  7. Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin, metronidazole or fidaxomicin) after the subjects last bout of CDAD

Exclusion Criteria:

  1. Subjects with known neutropenia with absolute neutrophil count <0.5 x 109/L
  2. Evidence of toxic megacolon, fulminant colitis, gastrointestinal perforation, ileus, abdominal distension, lack of bowel sounds, fever, or hypotension
  3. Known peripheral white blood cell count > 15.0 x 109/L or temperature > 38.0 °C
  4. Diarrhea due to definable non-CDAD pathogen
  5. Post total colectomy or presence of a colostomy
  6. Unable to tolerate FMT via enema for any reason
  7. Requiring systemic non-C. difficile antibiotic therapy at the time of FMT
  8. Actively taking Saccharomyces boulardii or other probiotic at the time of FMT
  9. Need for continuing use of oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT
  10. Renal failure requiring dialysis
  11. Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Sheri Allred, BS 8323554122 sheri.l.allred@uth.tmc.edu
Contact: Zhi-Dong Jiang, MD, Dr.PH 7135009371 zhi-dong.jiang@uth.tmc.edu

Locations
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    sheri.l.allred@uth.tmc.edu   
Contact: Zhi-Dong Jiang, MD, Dr.PH    7135009371    zhi-dong.jiang@uth.tmc.edu   
Principal Investigator: Herbert L DuPont, MD         
Sub-Investigator: Zhi-Dong Jiang, MD, DrPH         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Herbert l DuPont, MD University of Texas School of Public Health
  More Information

Publications:

Responsible Party: Zhi-Dong Jiang, associate professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02449174     History of Changes
Other Study ID Numbers: HSC-SPH-14-0020
First Submitted: December 17, 2014
First Posted: May 20, 2015
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by Zhi-Dong Jiang, The University of Texas Health Science Center, Houston:
C. difficile
Fecal Microbiota transplantation

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms