Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea

April 19, 2019 updated by: Zhi-Dong Jiang, The University of Texas Health Science Center, Houston
The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Housotn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Recipients

  • Male and female patients ≥ 18 years of age
  • Sexually active male and female patients of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
  • Female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
  • Required to sign an informed consent form
  • Deemed likely to survive for ≥ 3 months after enrolment
  • Diagnosis of ≥ 3 recurrent CDAD (RCDAD) bouts in outpatients or ≥ 2 bouts of CDAD in an inpatient without other explanation for diarrhea and with ≥ 2 positive fecal tests for C. difficile toxin
  • Referred by subjects attending physician who will provide non-transplant care for the subject and follow up at 1, 7, 14, 30 days after FMT
  • Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days
  • Anti-Clostridium difficile infection (CDI) antibiotic treatment stopped 2-4 days before the transplantation

Donors

  • Able to provide and sign informed consent
  • Able to complete and sign the donor questionnaire
  • Able to adhere to fecal transplantation stool collection requirements

Exclusion Criteria:

Recipients

  • Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
  • Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
  • Peripheral white blood cell count > 15.0 x 109/L AND temperature > 38.0 °C
  • Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or Campylobacter, and Norovirus
  • Presence of colostomy
  • Unable to tolerate human biotherapy (HBT) for any reason
  • Requiring systemic antibiotic therapy for more than 7 days
  • Actively taking Saccharomyces boulardii or other probiotic
  • 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
  • Prolonged compromised immunity due to cytotoxic chemotherapy or HIV infection

Donors

  • Test positive for any of variables
  • History of any type of active cancer or autoimmune disease
  • History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
  • History of gastrointestinal disorder, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
  • Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
  • Receipt of any type of live vaccine within 3 months prior to stool donation
  • Current or previous medical or psychosocial condition
  • Body mass index over 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fecal Microbiota_Fresh
Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (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 (250mL) was used within 2 hours of preparation (Fresh).
Biological: Fecal Microbiota
Fecal Microbiota will be delivered via colonoscopy.
Active Comparator: Fecal Microbiota_Frozen
Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 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 (250mL) was kept at -80 degrees Celsius (C) freezer labeled with identity (ID) and expiration date which was 6 months after preparation day (Frozen).
Biological: Fecal Microbiota
Fecal Microbiota will be delivered via colonoscopy.
Active Comparator: Fecal Microbiota_Lyophilized
Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 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 (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day.
Biological: Fecal Microbiota
Fecal Microbiota will be delivered via colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated Diarrhea (RCDAD) as Assessed by Number of Participants Who Any Adverse Event
Time Frame: 6 months
Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea
Time Frame: 30 days
a subsequent bout of C-diff associated diarrhea was defined as diarrhea, C. difficile toxins positive and using anti-C. difficile antibiotic treatment
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Herbert L DuPont, MD, The University of Texas Health Science Center, Houston
  • Principal Investigator: Zhi-Dong Jiang, MD, Dr.PH, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-13-0119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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