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)

Recurrent C. Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03298048
• Other study ID #: HSC-SPH-17-0614
• Status: Terminated
• Phase: Phase 2
• Start date: December 21, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 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

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

Related Conditions & MeSH terms

• Clostridium Infections
• Communicable Diseases
• Infection
• Recurrent C. Difficile Infection

Intervention

Biological:
• Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
• 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
• High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Assessed by Number of Participants With Nausea		180 days
Primary	Safety as Assessed by Number of Participants With Vomiting		180 days
Primary	Safety as Assessed by Number of Participants With Diarrhea		180 days
Primary	Safety as Assessed by Number of Participants With Bloating		180 days
Primary	Safety as Assessed by Number of Participants With Constipation		180 days
Secondary	Number of Participants With Recurrent C. Difficile Infection		6 months