Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases (GMT)

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: December 4, 2013
Last verified: December 2013

March 20, 2012
December 4, 2013
March 2012
December 2012   (final data collection date for primary outcome measure)
Clinical Response [ Time Frame: 4 weeks following GMT Treatment ] [ Designated as safety issue: Yes ]
Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment
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
Complete list of historical versions of study NCT01560819 on ClinicalTrials.gov Archive Site
Not Provided
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.
Not Provided
Not Provided
 
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

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 Clostridium 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 Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. 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.

Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Inflammatory Bowel Disease (IBD)
Drug: Gut Microbial Transplantation
Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.
Other Name: GMT
Experimental: Study Participants
Participants did not receive any bowel preparation before Gut Microbial Transplantation (GMT). Audio-visual aids were used to help reduce participants' anxiety about GMT.
Intervention: Drug: Gut Microbial Transplantation
Kunde S, Pham A, Bonczyk S, Crumb T, Duba M, Conrad H Jr, Cloney D, Kugathasan S. Safety, tolerability, and clinical response after fecal transplantation in children and young adults with ulcerative colitis. J Pediatr Gastroenterol Nutr. 2013 Jun;56(6):597-601. doi: 10.1097/MPG.0b013e318292fa0d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
December 2012   (final data collection date for primary outcome measure)

Participant Inclusion Criteria:

  1. Children ages >7 and ≤21 years of age with established diagnosis of Inflammatory Bowel Disease (IBD) colitis (patient with ulcerative colitis (UC) or patients with crohn's disease (CD) with colonic involvement only)
  2. Have clinical disease (mild to moderate disease: 10≤ Pediatric Ulcerative Colitis Activity Index (PUCAI) <65)
  3. Have stable disease activity and therapy for two months prior to Gut Microbial Transplantation (GMT) procedure.

Participant 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 tumor necrosis factor (TNF) inhibitors within 2 months prior to Day 1 of GMT or are expected to receive such therapy within 1 month post final GMT.

Donor Inclusion Criteria

  1. Based on patient's and parents'/guardian's decision
  2. Will be chosen from immediate adult (≥18 years) family members or close friends
  3. Should have negative or normal results on screening tests (as explained in donor exclusion criteria below)

Donor Exclusion Criteria (adopted from guidelines provided by American Association of Blood Bank Donor History Questionnaire and American Gastroenterological Association)

  1. Positive or abnormal screening test to include:

    1. Hepatitis A Immunoglobulin M (IgM) antibody
    2. Hepatitis B antibody panel suggestive of infection (HBc IgM, HBs Ag, HBs Ab)
    3. Hepatitis C antibody Level
    4. Cytomegalovirus (CMV) IgM antibody
    5. Ebstein Barr Virus (EBV) viral capsid antigen (VCA) IgM antibody
    6. Syphilis Immunoglobulin G (IgG) Ab Screen
    7. Human Immune Deficiency Virus (HIV) I & II enzyme-linked immunosorbent assay (ELISA) screen
    8. Stool i) Fungal smear ii) Stool cultures to exclude Salmonella, Shigella, Escherichia Coli, Campylobacter, Yersinia, Vibrio, Listeria iii) Clostridium difficile toxin assay iv) Ova and parasite screen for Giardia and Cryptosporidium
  2. History of metabolic syndrome or gastric bypass surgery
  3. History of GI conditions: IBD, irritable bowel syndrome, chronic abdominal pain, GI Malignancy, blood in stool or diarrhea in the last 4 weeks before enrollment
  4. Antibiotic or probiotic use within 3 months before enrollment and for the duration of the donation
  5. Positive response on screening questionnaire to any of the following:

    1. History of active malignancy or any cancer within the last 5 years (excluding basal cell carcinoma of the skin)
    2. Family history of Creutzfeld-Jacob disease
    3. Corneal or dural transplant
    4. History of high risk sexual behavior (e.g. sexual contact with HIV/acquired immune deficiency syndrome (AIDS) positive, hepatitis positive partner, men who have sex with men, sex for drugs or money)
    5. History of signs of sexually transmitted infections such as genital ulcerations, anogenital herpes, anogenital warts, cancroids or syphilitic lesions
    6. Use of illicit drugs
    7. Travel within the last 6 months to areas of the world where diarrheal illnesses are endemic
    8. History or signs of immunosuppression i) History of any immunosuppressant medication(s) within the last 6 months or history of opportunistic infection(s) in past 1 year ii) Signs of immunosuppression such as:
    1. Oral thrush
    2. Disseminated lymphadenopathy
Both
7 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01560819
2011-233
Yes
Spectrum Health Hospitals
Spectrum Health Hospitals
Not Provided
Principal Investigator: Sachin Kunde, MD, MPH Helen DeVos Children's Hospital of Spectrum Health Hospitals
Spectrum Health Hospitals
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP