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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)

R

Rebiotix

Status and phase

Completed
Phase 2

Conditions

Enterocolitis Clostridium Difficile Recurrent

Treatments

Other: Placebo
Biological: RBX2660 (microbiota suspension)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02299570
2014-01

Details and patient eligibility

About

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

Full description

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years
  • Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
  • Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
  • A positive stool test for the presence of C. difficile within 60 days prior to enrollment.

Exclusion criteria

  • A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
  • Requires antibiotic therapy for a condition other than recurrent CDI.
  • Previous fecal transplant prior to study enrollment.
  • History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • History of irritable bowel syndrome (IBS).
  • History of chronic diarrhea.
  • History of celiac disease.
  • Colostomy.
  • Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

150 participants in 3 patient groups, including a placebo group

Group A
Active Comparator group
Description:
Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
Treatment:
Biological: RBX2660 (microbiota suspension)
Group B
Placebo Comparator group
Description:
Two enemas of placebo administered 7 days apart
Treatment:
Other: Placebo
Group C
Active Comparator group
Description:
1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
Treatment:
Other: Placebo
Biological: RBX2660 (microbiota suspension)

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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