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Completed

NCT Number: NCT03110133

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.

Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.

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Key information

Conditions

Clostridium Difficile Infection Recurrence Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Diabetes Insipidus Diabetes Insipidus, Neurogenic Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Infections Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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About this study

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent
  • Men or women 18 years of age or older
  • Current diagnosis of a recurrence of non-severe, non-complicated CDI
  • Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode

Exclusion criteria

  • Pregnant, breast-feeding, or considering becoming pregnant during the study
  • Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
  • Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
  • Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
  • Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
  • Major intra-abdominal surgery within the past 60 days prior to Screening
  • History of total colectomy/ileostomy or bariatric surgery
  • Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
  • Planned hospitalization or invasive surgery during the study
  • Severe acute illness unrelated to CDI

Treatment and study plan

Full Spectrum Microbiota

Drug

Orally administered donor derived microbiota

Other names: CP101, FSM

Placebo

Drug

Placebo for CP101

Primary outcomes

  1. Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication

    Time frame: Week 8

    Defined in the protocol as sustained clinical cure

  2. Number of Participants With Occurrence of Treatment Emergent Adverse Events

    Time frame: Week 8

    Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)

Secondary outcomes

  1. Time to First Recurrent CDI Episode During the Study

    Time frame: Week 8

    The number of days between IP administration and the first C. Difficile recurrence

  2. Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication

    Time frame: Week 24

    Defined in the protocol as sustained clinical cure

  3. Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype

    Time frame: Up to Week 8

    NAP1 is the North American Pulse-field C. difficile subtype.

Sponsors and collaborators

Lead sponsor

Finch Research and Development LLC.

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Acronym: PRISM3

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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