Trial record 2 of 161 for:    fecal | Recruiting | Exclude Unknown | United States

Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MemorialCare Health System
Sponsor:
Information provided by (Responsible Party):
Sonia Michail, MD, MemorialCare Health System
ClinicalTrials.gov Identifier:
NCT01972334
First received: October 18, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.


Condition Intervention Phase
Clostridium Difficile Colitis
Biological: FMT
Biological: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Pilot Trial to Administer Fecal Microbial Therapy (Stool Transplant) or Placebo in Children Ages 8 to 18 With Recurrent C. Difficile Infection

Resource links provided by NLM:


Further study details as provided by MemorialCare Health System:

Primary Outcome Measures:
  • The primary efficacy outcome of this randomized, controlled, double-blinded study is the time of recurrence of an infection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    secondary outcome measures are focused on the safety of Fecal microbial transplant in this population and all subjects will be closely monitored for developing adverse events for 12 months


Secondary Outcome Measures:
  • safety of fecal microbial transplant in children with recurrent clostridium difficile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    All subjects will be closely monitored for adverse events for 12 months after fecal transplant. Subjects will be asked to report any adverse events as they occur and will also be monitored during each visits especially fever, bloating, abdominal pain, vomiting, diarrhea, and rectal bleeding.


Estimated Enrollment: 46
Study Start Date: October 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMT or fecal microbial transplant
intervention is fecal microbial transplant done through endoscopy, subjects will be randomized 1:1 to receive either FMT or placebo
Biological: FMT
as explained in study arm
Other Names:
  • FMT
  • fecal microbial transplant
  • stool transplant
Placebo Comparator: placebo
1:1 randomization to FMT versus placebo (which is saline or salt water)
Biological: placebo
salt water or saline will be given as placebo
Other Names:
  • saline
  • salt water

Detailed Description:

Forty six children with recurrent C. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. The safety and efficacy of this intervention will be monitored for one year.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 1-21.
  2. Recurrent C. difficile infection defined as the occurrence of more than two infections

Exclusion Criteria:

  1. Inflammatory bowel disease
  2. Immune-deficiency.
  3. Allergy to oral vancomycin.
  4. Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.
  5. Concurrent infections that require anti-microbial therapy.
  6. Unable to give informed consent/assent.
  7. Pregnancy.
  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: NCT01972334

Contacts
Contact: Sonia Michail, MD 562-933-5607 sonia.michail@hotmail.com
Contact: Nan O'Donnell, RN, MS 562-933-5607 nodonnell@memorialcare.org

Locations
United States, California
Miller Children's Hospital Recruiting
Los Angeles, California, United States, 90806
Contact: Nan O'Donnell, RN    562-933-5607    odonnell@memorialcare.org   
Principal Investigator: Sonia Michail, MD         
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sonia Michail, MD    323-361-8631    sonia.michail@hotmail.com   
Principal Investigator: Sonia Michail, MD         
Sponsors and Collaborators
MemorialCare Health System
  More Information

No publications provided

Responsible Party: Sonia Michail, MD, MD, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT01972334     History of Changes
Other Study ID Numbers: 093-12
Study First Received: October 18, 2013
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by MemorialCare Health System:
clostridium difficile
children
fecal transplant

Additional relevant MeSH terms:
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 31, 2014