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

Description

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

Study Start Date

May, 08 2017

Estimated Completion Date

May 2019

Interventions

  • Drug: Placebo
  • Drug: Full Spectrum Microbiota

Study ID

Crestovo LLC -- CDI-001

Status

Recruiting

Trial ID

NCT03110133

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

240

Sponsor

Crestovo LLC

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 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
  • 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (173)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Parker Jewish Institute for Health Care Rehabilitation - New Hyde Park, New York 174.3 miles None None None
Parker Jewish Institute for Health Care Rehabilitation - New Hyde Park, New York 174.3 miles None None None
Parker Jewish Institute for Health Care Rehabilitation - New Hyde Park, New York 174.3 miles None None None
Parker Jewish Institute for Health Care Rehabilitation - New Hyde Park, New York 174.3 miles None None None
Parker Jewish Institute for Health Care Rehabilitation - New Hyde Park, New York 174.3 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
New YorkPresbyterianQueens - Flushing, New York 179.8 miles None None None
New YorkPresbyterianQueens - Flushing, New York 179.8 miles None None None
New YorkPresbyterianQueens - Flushing, New York 179.8 miles None None None
New YorkPresbyterianQueens - Flushing, New York 179.8 miles None None None
New YorkPresbyterianQueens - Flushing, New York 179.8 miles None None None
South Jersey Infectious Disease - Somers Point, New Jersey 279.3 miles None None None
South Jersey Infectious Disease - Somers Point, New Jersey 279.3 miles None None None
South Jersey Infectious Disease - Somers Point, New Jersey 279.3 miles None None None
South Jersey Infectious Disease - Somers Point, New Jersey 279.3 miles None None None
South Jersey Infectious Disease - Somers Point, New Jersey 279.3 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins - Baltimore, Maryland 356.0 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 366.9 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 366.9 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 366.9 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 366.9 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 366.9 miles None None None
Chevy Chase Clinical Research - Chevy Chase, Maryland 391.7 miles None None None
Chevy Chase Clinical Research - Chevy Chase, Maryland 391.7 miles None None None
Chevy Chase Clinical Research - Chevy Chase, Maryland 391.7 miles None None None
Chevy Chase Clinical Research - Chevy Chase, Maryland 391.7 miles None None None
Chevy Chase Clinical Research - Chevy Chase, Maryland 391.7 miles None None None
Washington DC Veterans Affairs Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Washington DC Veterans Affairs Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Exemplar Research - Elkins, West Virginia 517.6 miles None None None
Exemplar Research - Elkins, West Virginia 517.6 miles None None None
Exemplar Research - Elkins, West Virginia 517.6 miles None None None
Exemplar Research - Elkins, West Virginia 517.6 miles None None None
Great Lakes Gastroenterology Research - Mentor, Ohio 529.0 miles None None None
Infectious Diseases Associates of Central Virginia - Lynchburg, Virginia 549.4 miles None None None
Infectious Diseases Associates of Central Virginia - Lynchburg, Virginia 549.4 miles None None None
Infectious Diseases Associates of Central Virginia - Lynchburg, Virginia 549.4 miles None None None
Infectious Diseases Associates of Central Virginia - Lynchburg, Virginia 549.4 miles None None None
Coastal Carolina Health Care - New Bern, North Carolina 599.8 miles None None None
Coastal Carolina Health Care - New Bern, North Carolina 599.8 miles None None None
Coastal Carolina Health Care - New Bern, North Carolina 599.8 miles None None None
Kinston Medical Specialists - Kinston, North Carolina 603.2 miles None None None
Kinston Medical Specialists - Kinston, North Carolina 603.2 miles None None None
Kinston Medical Specialists - Kinston, North Carolina 603.2 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 625.6 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 625.6 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 625.6 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 625.6 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 625.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Kentucky - Lexington, Kentucky 769.1 miles None None None
University of Kentucky - Lexington, Kentucky 769.1 miles None None None
University of Kentucky - Lexington, Kentucky 769.1 miles None None None
University of Kentucky - Lexington, Kentucky 769.1 miles None None None
University of Kentucky - Lexington, Kentucky 769.1 miles None None None
University of Chicago - Chicago, Illinois 848.0 miles None None None
University of Chicago - Chicago, Illinois 848.0 miles None None None
University of Chicago - Chicago, Illinois 848.0 miles None None None
Emory University - Decatur, Georgia 932.0 miles None None None
Emory University - Decatur, Georgia 932.0 miles None None None
Emory University - Decatur, Georgia 932.0 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
BorlandGroover Clinic - Jacksonville, Florida 1,021.9 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles None None None
Clinical Research Solutions - Jackson, Tennessee 1,057.2 miles None None None
Clinical Research Solutions - Jackson, Tennessee 1,057.2 miles None None None
Clinical Research Solutions - Jackson, Tennessee 1,057.2 miles None None None
Clinical Research Solutions - Jackson, Tennessee 1,057.2 miles None None None
Clinical Research Solutions - Jackson, Tennessee 1,057.2 miles None None None
Regions Hospital - Saint Paul, Minnesota 1,112.4 miles None None None
Regions Hospital - Saint Paul, Minnesota 1,112.4 miles None None None
Regions Hospital - Saint Paul, Minnesota 1,112.4 miles None None None
Regions Hospital - Saint Paul, Minnesota 1,112.4 miles None None None
Regions Hospital - Saint Paul, Minnesota 1,112.4 miles None None None
Omega Research Consultants - Orlando, Florida 1,114.6 miles None None None
Omega Research Consultants - Orlando, Florida 1,114.6 miles None None None
Omega Research Consultants - Orlando, Florida 1,114.6 miles None None None
Omega Research Consultants - Orlando, Florida 1,114.6 miles None None None
Midway Immunology and Research Center - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center - Fort Pierce, Florida 1,160.6 miles None None None
Theia Clinical Research - Pinellas Park, Florida 1,199.9 miles None None None
Theia Clinical Research - Pinellas Park, Florida 1,199.9 miles None None None
Theia Clinical Research - Pinellas Park, Florida 1,199.9 miles None None None
Ocean Blue Medical Research Center - Miami Springs, Florida 1,259.7 miles None None None
Ocean Blue Medical Research Center - Miami Springs, Florida 1,259.7 miles None None None
Ocean Blue Medical Research Center - Miami Springs, Florida 1,259.7 miles None None None
Lone Star Research Center - Miami, Florida 1,262.6 miles None None None
Lone Star Research Center - Miami, Florida 1,262.6 miles None None None
Lone Star Research Center - Miami, Florida 1,262.6 miles None None None
Health and Life Research Institute - Miami, Florida 1,265.3 miles None None None
Biotech Pharmaceutical Group - Miami, Florida 1,265.3 miles None None None
Biotech Pharmaceutical Group - Miami, Florida 1,265.3 miles None None None
Health and Life Research Institute - Miami, Florida 1,265.3 miles None None None
Biotech Pharmaceutical Group - Miami, Florida 1,265.3 miles None None None
Health and Life Research Institute - Miami, Florida 1,265.3 miles None None None
Gastroenterology Group of Naples - Naples, Florida 1,277.5 miles None None None
Gastroenterology Group of Naples - Naples, Florida 1,277.5 miles None None None
Gastroenterology Group of Naples - Naples, Florida 1,277.5 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles None None None
Rapid City Medical Center - Rapid City, South Dakota 1,612.9 miles None None None
Rapid City Medical Center - Rapid City, South Dakota 1,612.9 miles None None None
Rapid City Medical Center - Rapid City, South Dakota 1,612.9 miles None None None
Rapid City Medical Center - Rapid City, South Dakota 1,612.9 miles None None None
Rapid City Medical Center - Rapid City, South Dakota 1,612.9 miles None None None
Mercury Street Medical Group - Butte, Montana 2,049.8 miles None None None
Mercury Street Medical Group - Butte, Montana 2,049.8 miles None None None
Mercury Street Medical Group - Butte, Montana 2,049.8 miles None None None
Mercury Street Medical Group - Butte, Montana 2,049.8 miles None None None
Mercury Street Medical Group - Butte, Montana 2,049.8 miles None None None
Snake River Research - Idaho Falls, Idaho 2,055.7 miles None None None
Snake River Research - Idaho Falls, Idaho 2,055.7 miles None None None
Snake River Research - Idaho Falls, Idaho 2,055.7 miles None None None
Care Access Research - Salt Lake City, Utah 2,095.1 miles None None None
Care Access Research - Salt Lake City, Utah 2,095.1 miles None None None
Advanced Clinical Research - Riverton, Utah 2,104.8 miles None None None
Advanced Clinical Research - Riverton, Utah 2,104.8 miles None None None
Advanced Clinical Research - Riverton, Utah 2,104.8 miles None None None
Advanced Clinical Research - Riverton, Utah 2,104.8 miles None None None
Mayo Clinic - Phoenix, Arizona 2,284.5 miles None None None
Mayo Clinic - Phoenix, Arizona 2,284.5 miles None None None
Mayo Clinic - Phoenix, Arizona 2,284.5 miles None None None
MidColumbia Research - Richland, Washington 2,366.7 miles None None None
MidColumbia Research - Richland, Washington 2,366.7 miles None None None
MidColumbia Research - Richland, Washington 2,366.7 miles None None None
MidColumbia Research - Richland, Washington 2,366.7 miles None None None
MidColumbia Research - Richland, Washington 2,366.7 miles None None None
United Gastroenterologists - Murrieta, California 2,555.9 miles None None None
United Gastroenterologists - Murrieta, California 2,555.9 miles None None None
United Gastroenterologists - Murrieta, California 2,555.9 miles None None None
eStudy Site - La Mesa, California 2,573.5 miles None None None
eStudy Site - La Mesa, California 2,573.5 miles None None None
eStudy Site - La Mesa, California 2,573.5 miles None None None
Alliance Research Centers - Laguna Hills, California 2,582.4 miles None None None
Alliance Research Centers - Laguna Hills, California 2,582.4 miles None None None
Alliance Research Centers - Laguna Hills, California 2,582.4 miles None None None
Ventura Clinical Trials - Ventura, California 2,638.1 miles None None None
Ventura Clinical Trials - Ventura, California 2,638.1 miles None None None
Ventura Clinical Trials - Ventura, California 2,638.1 miles None None None
Ventura Clinical Trials - Ventura, California 2,638.1 miles None None None

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