Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

NCT ID: NCT01972334

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-07-31

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.

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.

Conditions

Clostridium Difficile Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

FMT

Intervention Type: BIOLOGICAL

as explained in study arm

placebo

1:1 randomization to FMT versus placebo (which is saline or salt water)

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

salt water or saline will be given as placebo

Interventions

FMT

as explained in study arm

Intervention Type: BIOLOGICAL

placebo

salt water or saline will be given as placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

fecal microbial transplant; stool transplant; saline; salt water

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Medical Center Foundation

OTHER

Sponsor Role: collaborator

MemorialCare Health System

OTHER

Sponsor Role: lead

Responsible Party

Sonia Michail, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Michail, MD

Role: PRINCIPAL_INVESTIGATOR

MemorialCare Health Servies

Locations

Miller Children's Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

093-12

Identifier Type: -

Identifier Source: org_study_id