Fecal Microbiota Transplantation in Pediatric Patients

NCT02108821 | Completed Phase 1 Results DMC

• 1 other identifier: PRO13030081
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

A disturbance in the diversity of gut bacterial composition could be linked to several immune mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal immune reaction to resident gut bacteria.The process of fecal microbiota transplantation (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has recently received attention as an alternative therapy for individuals affected with these life-altering diseases. In this study, the investigators will perform fecal transplantation on the subjects meeting inclusion criteria, to determine the efficacy and safety of this therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and are in a flare.

Conditions

Inflammatory Bowel Diseases (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)

Keywords

Inflammatory Bowel Diseases (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term

  Adverse events recorded to determine safety of Fecal Microbiome Transplant in the treatment of children with IBD.

  6 months

Secondary Outcomes (1)

• Examine the Efficacy of Fecal Microbiome Transplant in the Treatment of Children With IBD Using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) Analysis.

  Baseline, Day 30, Day 180

Study Arms (1)

Fecal Microbiome Transplantation

EXPERIMENTAL

Fecal Microbiome Transplantation will be done at the time of EGD and colonoscopy. A parent or sibling or a healthy relative will be tested for several infections like hepatitis, H. Pylori, HIV, syphilis, ova and parasites, culture and C.diff. They will fill out a donor questionnaire used for blood donors prior to the sample collection. After eligibility criteria have been met, appropriate consent has been obtained, and the screening labs have been assessed, the fecal transplant procedure will take place in the procedure center at Children's Hospital of Pittsburgh. Fresh stool sample will be obtained from the donor. The fecal sample will be prepared for transplantation in a designated area in the procedure center. Frequency: once. Duration: Approximately 1 hour

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).

Also known as: Fecal Transplantation

Fecal Microbiome Transplantation

Eligibility Criteria

• Age: 2 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current IBD patients who have:
• UC patients with a flare due to failure of current therapy and have to undergo esophagogastroduodenoscopy (EGD) and colonoscopy for restaging the disease and escalation of therapy.
• CD patients with ileo colonic or colonic disease who require an EGD and colonoscopy for disease assessment due to a flare or poor control.
• The ability to safely undergo colonoscopy (physical status classification used by the American Society of Anesthesiologists).
• PUCAI score less than sixty five.
• PCDAI score less than forty.

You may not qualify if:

• Patients with Crohn's disease: complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection as causes for flare up before being deemed eligible for recruitment to the study. We will check for these complications if a recent study has not been done.
• Severe immunosuppression: Biologicals with concomitant steroids (\>30 mg/day).
• Central Line.
• Pressor or ventilatory support.
• On antibiotics.
• Patients with Crohn's disease found to have complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection.
• Not willing to consent or follow guidelines throughout research trial.
• Physician discretion.
• Participant request.
• A history of antibiotic treatment during the 3 months preceding donation.
• A history of intrinsic gastrointestinal illnesses.
• A history of autoimmune or atopic illness or modulating therapy.
• A history of chronic pain syndromes, or neurologic or neurodevelopmental disorders.
• Metabolic syndrome or malnutrition or obesity.
• A history of exposure to infectious agents.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Pittsburgh: collaborator
• Stanford University: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Limitations and Caveats

small number of subjects, open label trial, fecal calprotectin not collected in every subject so response measurement was subjective

Results Point of Contact

• Title: Alka Goyal MD
• Organization: Children's Mercy Hospital, Kansas City

agoyal4@stanford.edu

816-302-3069

Study Officials

• Alka Goyal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 9, 2014
• Study Start: March 1, 2014
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-02

Locations

US (1)