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Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

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ClinicalTrials.gov Identifier: NCT01972334
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Memorial Medical Center Foundation
Information provided by (Responsible Party):
Sonia Michail, MD, MemorialCare Health System

Brief Summary:
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 or disease Intervention/treatment Phase
Clostridium Difficile Colitis Biological: FMT Biological: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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:
  • 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




Primary Outcome Measures :
  1. The primary efficacy outcome of this randomized, controlled, double-blinded study is the time of recurrence of an infection [ Time Frame: 12 months ]
    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 :
  1. safety of fecal microbial transplant in children with recurrent clostridium difficile [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972334


Locations
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United States, California
Miller Children's Hospital
Los Angeles, California, United States, 90806
Sponsors and Collaborators
MemorialCare Health System
Memorial Medical Center Foundation
Investigators
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Principal Investigator: Sonia Michail, MD MemorialCare Health Servies

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Responsible Party: Sonia Michail, MD, MD, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT01972334     History of Changes
Other Study ID Numbers: 093-12
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sonia Michail, MD, MemorialCare Health System:
clostridium difficile
children
fecal transplant

Additional relevant MeSH terms:
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Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases