Randomized Clinical Trial of Standard FMT Treatments

NCT04729790 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HSC-SPH-19-0950
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by number of participants with treatment-related adverse events

  60 days

Study Arms (2)

Patients with RCDI will receive FMT capsules from single donor

ACTIVE COMPARATOR

Capsules made with intestinal bacteria from single healthy donor 1. st treatment day, lyophilized product generated from single donor (90g of stool) 2. nd treatment day, lyophilized product generated from single donor (90g of stool)

Drug: PRIM-DJ2727

Patient will receive FMT capsules from three donors

EXPERIMENTAL

Capsules made of intestinal bacteria from three healthy donors 1. st treatment day, lyophilized product generated from three donors (90g of stool) 2. nd treatment day, lyophilized product generated from three donors (90g of stool)

Drug: PRIM-DJ2727

Interventions

PRIM-DJ2727 DRUG

oral FMT capsules

Patient will receive FMT capsules from three donors; Patients with RCDI will receive FMT capsules from single donor

Eligibility Criteria

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

You may qualify if:

• Male and female subjects 18 years of age or older.
• Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
• Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
• Subject/LAR willing and able to provide informed consent.
• Able to follow study procedures and complete the follow-up questionnaire for safety.
• Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
• Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
• Received at least two courses of standard-of-care antibiotic therapy for CDI.

You may not qualify if:

• Unable to take capsules orally.
• Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
• Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
• Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
• Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
• Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
• Life expectancy of \< 6 months.
• In the opinion of investigator, subject for any reason, should be excluded from the study.

Sponsors & Collaborators

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

Study Officials

• Herbert l DuPont, MD

  University of Texas Health Science Center School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent statistician will develop a randomization list using SAS. Randomization in permuted blocks will be used to achieve balance across treatment groups. The randomization scheme consists of a sequence of blocks such that each block contains a pre-specified number of treatment assignments in random order. The purpose of this is to balance the randomization scheme at the completion of each block. The target sample size is 200 evaluable subjects or as many as can be done up to that number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases

Model Details: This is a double-blinded study for the groups randomized to receive FMT products either from single or three healthy donors

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 29, 2021
• Study Start: January 10, 2020
• Primary Completion: January 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share