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Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)

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ClinicalTrials.gov Identifier: NCT03298048
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Herbert DuPont, The University of Texas Health Science Center, Houston

Brief Summary:
To establish optimal dosing of lyophilized FMT product in the treatment of recurrent C. difficile infection

Condition or disease Intervention/treatment Phase
Recurrent C. Difficile Infection Biological: Low fecal microbiota dose Biological: Mid fecal microbiota dose Biological: High fecal microbiota dose Phase 2

Detailed Description:
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase II. Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Biological: Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Other Name: Fecal microbiota transplantation (FMT)

Active Comparator: Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
Biological: Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
Other Name: Fecal microbiota transplantation (FMT)

Active Comparator: High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Biological: High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Other Name: Fecal microbiota transplantation (FMT)




Primary Outcome Measures :
  1. Safety as assessed by number of participants with nausea [ Time Frame: 180 days ]
  2. Safety as assessed by number of participants with vomiting [ Time Frame: 180 days ]
  3. Safety as assessed by number of participants with diarrhea [ Time Frame: 180 days ]
  4. Safety as assessed by number of participants with bloating [ Time Frame: 180 days ]
  5. Safety as assessed by number of participants with constipation [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Number of participants with recurrent C. difficile infection [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
  • Subject willing to sign an informed consent form
  • Subject deemed likely to survive for ≥ 1 year after enrollment
  • Able to follow study procedure and follow-ups
  • Subjects' attending physician will provide non-transplant care for the subject
  • Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of RCDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
  • Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
  • Have a 4C refrigerator at home to keep the second dose FMT for overnight

Exclusion Criteria:

  • Unable to take capsules orally
  • Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
  • Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
  • Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
  • 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

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): NCT03298048


Contacts
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Contact: Herbert L DuPont, MD 713 500 9366 herbert.l.dupont@uth.tmc.edu
Contact: zhi-dong jiang, Dr.PH 713 500 9371 zhi-dong.jiang@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Housotn Recruiting
Houston, Texas, United States, 77030
Contact: Zhi-Dong Jiang, Dr.PH    713-500-9371    zhi-dong.jiang@uth.tmc.edu   
Contact: Herbert L DuPont, MD    7135009366    herbert.l.dupont@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
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Principal Investigator: Herbert L DuPont, MD UTHealth School of Public Health

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Responsible Party: Herbert DuPont, Professor of Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03298048     History of Changes
Other Study ID Numbers: HSC-SPH-17-0614
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections