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

This study is currently recruiting participants.

See

Contacts and Locations

Verified August 2017 by Crestovo LLC

Sponsor:

Information provided by (Responsible Party):

Crestovo LLC

ClinicalTrials.gov Identifier:

NCT03110133

First received: April 3, 2017

Last updated: August 24, 2017

Last verified: August 2017

History of Changes

Purpose

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

Condition	Intervention	Phase
Clostridium Difficile Infection Recurrence	Drug: Full Spectrum Microbiota Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official 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

Further study details as provided by Crestovo LLC:

Primary Outcome Measures:

Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]
Sustained clinical cure rate
Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]
Mapped to System Organ Class

Secondary Outcome Measures:

Sustained clinical cure of CDI by C. difficile subtype [ Time Frame: Week 8 ]
Proportion of subjects sustaining clinical cure by C. difficile subtype
Time to first recurrent CDI episode during the study [ Time Frame: Week 8 and Week 24 ]
Time to first recurrence of C. difficile
Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 24 ]
Sustained clinical cure rate


Estimated Enrollment:	240
Actual Study Start Date:	May 8, 2017
Estimated Study Completion Date:	May 2019
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High Dose High Dose Full Spectrum Microbiota	Drug: Full Spectrum Microbiota Orally administered donor derived microbiota Other Name: CP101, FSM
Experimental: Low Dose Low dose Full Spectrum Microbiota	Drug: Full Spectrum Microbiota Orally administered donor derived microbiota Other Name: CP101, FSM
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo for CP101

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide written informed consent
Men or women age 18 to 85 years of age, inclusive
Current diagnosis of a recurrence of non-severe, non-complicated CDI
Subject has a clinical response to a standard course of oral vancomycin therapy to treat the current episode of recurrent CDI

Exclusion Criteria:

Pregnant, breast-feeding, or considering becoming pregnant during the study
Current administration of a long-term vancomycin regimen (step reduction or pulse)
Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
Any prior diagnosis of irritable bowel syndrome (IBS), or currently meets Rome III criteria for IBS.
Systemic chemotherapy for the treatment of cancer during the 60 days prior to consent or planned during the study
Prior fecal transplant for any condition, regardless of route of administration
Presence of ileostomy or colostomy, or history of prior gastric resection or significant colon resection
Planned hospitalization or invasive surgery during the study
Severe acute illness unrelated to CDI

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03110133

Contacts


Contact: Kirk Taylor, MD	617-315-2138	trialinfo@crestovo.com

Show 43 Study Locations

Sponsors and Collaborators

Crestovo LLC

More Information


Responsible Party:	Crestovo LLC
ClinicalTrials.gov Identifier:	NCT03110133 History of Changes
Other Study ID Numbers:	CDI-001
Study First Received:	April 3, 2017
Last Updated:	August 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Crestovo LLC:


Clostridium Difficile Infection CP101 Crestovo	FMT CDI C. difficile

Additional relevant MeSH terms:


Infection Recurrence Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017

To Top