Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

Clostridium Difficile Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972334
• Other study ID #: 093-12
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2013
• Last updated: August 30, 2016
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: MemorialCare Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Colitis
• Colitis

Intervention

Biological:
• FMT
as explained in study arm
• placebo
salt water or saline will be given as placebo

Locations

Country	Name	City	State
United States	Miller Children's Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
MemorialCare Health System	Memorial Medical Center Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome of this randomized, controlled, double-blinded study is the time of recurrence of an infection	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	12 months	Yes
Secondary	safety of fecal microbial transplant in children with recurrent clostridium difficile	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.	12 months	Yes