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Fecal Microbiota Transplantation in Pediatric Patients (FMT)

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ClinicalTrials.gov Identifier: NCT02108821
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Alka, Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC) Biological: Fecal Microbiota Transplantation (FMT) Phase 1

Detailed Description:
50 subjects (25 subjects with Crohn's Disease and 25 subjects with Ulcerative Colitis) who are 2 to 22 years of age will be enrolled in the trial over 3 years. The fecal donors, preferably a parent or sibling, will be extensively screened for infectious diseases prior to providing stool for the transplant. Patients who are failing primary therapy, are in a flare, and require restaging of their IBD by an endoscopy and colonoscopy will be approached for the study. Standard of care endoscopy and colonoscopy will be performed on each subject and 2 additional biopsies will be taken for analysis. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 1 week, 1 month, and 6 months post transplantation. The primary objective will be to study the safety of FMT in all enrolled subjects. The study will also correlate efficacy and patient outcomes with the fecal microbiome prior to, and after FMT. The secondary objectives are to examine the efficacy of FMT in the treatment of children with IBD using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis. Correlate the patient outcomes with the fecal microbiome prior to, and after FMT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.
Study Start Date : September 2014
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : July 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal Microbiome Transplantation
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)
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).
Other Name: Fecal Transplantation




Primary Outcome Measures :
  1. Primary Objective: Study the safety of Fecal Microbiome Transplantation in patients with Inflammatory Bowel Diseases by assessing change in fecal microbiome. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplantation. ]
    Correlate safety and patient outcomes with fecal microbiome prior to and after Fecal Microbiome Transplantation.


Secondary Outcome Measures :
  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, and assessing the change. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplant. ]
    Examine the efficacy of Fecal Microbiome Transplantation in the treatment of children with IBD using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis, and assessing the change in the PUCAI or the PCDAI analysis.

  2. Correlate the patient outcomes with the fecal microbiome prior to, and after Fecal Microbiome Transplantation. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplantation. ]
    Correlate the patient outcomes with the fecal microbiome prior to, and after Fecal Microbiome Transplantation.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

STUDY SUBJECT INCLUSION CRITERIA:

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.

STUDY SUBJECTS EXCLUSION CRITERIA:

  • 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.
  • Screening labs in either donor or recipient reveal problems with performing fecal microbiome transplantation because inclusion requirements are no longer met.
  • Physician discretion.
  • Participant request.

DONOR EXCLUSION CRITERIA:

  • 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.
  • Diarrhea or other symptoms of an intestinal infection within two weeks prior to, or on the day of, stool donation.
  • A history of malignant illnesses or ongoing oncologic therapy.
  • Weight less than 15 kgs.

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): NCT02108821


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Pittsburgh
Investigators
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Principal Investigator: Alka Goyal, MD Children's Mercy Hospital Kansas City
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Responsible Party: Alka, Associate Professor of Pediatrics, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02108821    
Other Study ID Numbers: PRO13030081
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Alka, Children's Mercy Hospital Kansas City:
Inflammatory Bowel Diseases (IBD)
Crohn's Disease (CD)
Ulcerative Colitis (UC)
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes