Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

NCT01972334 | Completed Phase 2

• 1 other identifier: 093-12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Colitis

Keywords

clostridium difficile; children; fecal transplant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• safety of fecal microbial transplant in children with recurrent clostridium difficile

  12 months

Study Arms (2)

FMT or fecal microbial transplant

EXPERIMENTAL

intervention is fecal microbial transplant done through endoscopy, subjects will be randomized 1:1 to receive either FMT or placebo

Biological: FMT

placebo

PLACEBO COMPARATOR

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

Biological: placebo

Interventions

FMT BIOLOGICAL

as explained in study arm

Also known as: fecal microbial transplant, stool transplant

FMT or fecal microbial transplant

placebo BIOLOGICAL

salt water or saline will be given as placebo

Also known as: saline, salt water

placebo

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MemorialCare Health System: lead
• Memorial Medical Center Foundation: collaborator

Study Sites (1)

Miller Children's Hospital

Los Angeles, California, 90806, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

Fecal Microbiota Transplantation; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Officials

• Sonia Michail, MD

  MemorialCare Health Servies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

US (1)