Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | March 2012 |
| End Date: | May 2013 |
| Contact: | Teri Crumb, BSN, RN, CCRC |
| Email: | teri.crumb@spectrumhealth.org |
| Phone: | 616-391-9367 |
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.
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.
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