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Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT01560819
First received: March 20, 2012
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for C. difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.

This research will be conducted in the HDVCH Pediatric GI outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patient with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Donors will be chosen by the family, inclusive immediate family members and friends. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.


Condition Intervention Phase
Pediatric Inflammatory Bowel Disease
 Drug: Gut microbial transplantation
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 4 weeks following GMT Treatment ] [ Designated as safety issue: Yes ]
    Clinical response (i.e. improvement in PUCAI score by greater than or equal to 10 points from baseline) at 4 weeks following GMT treatment


Secondary Outcome Measures:
  • Continued Clinical Response [ Time Frame: 6 months after GMT Treatment ] [ Designated as safety issue: Yes ]
    continued clinical response (i.e. improvement in PUCAI score by greater than or equal to 10 points from basline) at 6 months after GMT treatment.


Enrollment: 10
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gut microbial transplantation
    Gut microbial transplantation
  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children ages > 7 and ≤21 yrs of age with established diagnosis of IBD colitis (patient with UC or patients with CD with colonic involvement only)
  2. Have clinical disease (mild to moderate disease: 10 ≤ PUCAI < 65; see below)
  3. Have stable disease activity and therapy for two months prior to GMT procedure.

Exclusion Criteria:

  1. Fulminant colitis
  2. Indication or scheduled for surgery
  3. Pregnancy
  4. Use of probiotic supplements during the study period (subjects who have stopped use of probiotic supplements will be eligible as long as they stop taking it 2 weeks prior to Day 1 of GMT)
  5. anemia (hemoglobin < 6.0 g/dL) in last one month
  6. Graft versus host disease (GVHD)

  7. Severely immunocompromised - defined as

    1. History of opportunistic infection (tuberculosis, Pneumocystis jirovecii or systemic fungal infections) in last one year or
    2. Neutropenia: Absolute neutrophil count (ANC) <500
  8. Major intra-abdominal surgery within 90 days prior to Day 1 of GMT
  9. Administration of any investigational drug within 30 days prior to Day 1 of GMT.
  10. Have received infliximab or other TNF inhibitors within 2 months prior to Day 1 of GMT or are expected to receive such therapy within 1 month post final GMT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560819

Locations
United States, Michigan
Helen DeVos Childrens Hospital (HDVCH)
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
Principal Investigator: Sachin Kunde, MD, MPH Helen DeVos Childrens Hospital
  More Information

No publications provided

Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT01560819     History of Changes
Other Study ID Numbers: 2011-233
Study First Received: March 20, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Health Hospitals:
Inflammatory Bowel Disease, pediatric, ulcerative colitis, fecal bacteriotherapy, fecal transplant, fecal microbial transplantation

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013