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)

NCT03298048 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HSC-SPH-17-0614
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

Conditions

Recurrent C. Difficile Infection

Outcome Measures

Primary Outcomes (5)

• Safety as Assessed by Number of Participants With Nausea

  180 days

• Safety as Assessed by Number of Participants With Vomiting

  180 days

• Safety as Assessed by Number of Participants With Diarrhea

  180 days

• Safety as Assessed by Number of Participants With Bloating

  180 days

• Safety as Assessed by Number of Participants With Constipation

  180 days

Secondary Outcomes (1)

• Number of Participants With Recurrent C. Difficile Infection

  6 months

Study Arms (3)

Low fecal microbiota dose

ACTIVE COMPARATOR

receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days

Biological: Low fecal microbiota dose

Mid fecal microbiota dose

ACTIVE COMPARATOR

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

High fecal microbiota dose

ACTIVE COMPARATOR

receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Biological: High fecal microbiota dose

Interventions

Low fecal microbiota dose BIOLOGICAL

receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days

Also known as: Fecal microbiota transplantation (FMT)

Low fecal microbiota dose

Mid fecal microbiota dose BIOLOGICAL

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

Also known as: Fecal microbiota transplantation (FMT)

Mid fecal microbiota dose

High fecal microbiota dose BIOLOGICAL

receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Also known as: Fecal microbiota transplantation (FMT)

High fecal microbiota dose

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 recurrent CDI 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 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Herbert DuPont
• Organization: UTexas_Houston

herbert.l.dupont@uth.tmc.edu

713-500-9366

Study Officials

• Herbert L DuPont, MD

  UTHealth School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: December 21, 2017
• Primary Completion: March 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)