Fecal Microbiota Transplantation in Pediatric Patients (FMT)
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ClinicalTrials.gov Identifier: NCT02108821 |
Recruitment Status :
Completed
First Posted : April 9, 2014
Results First Posted : February 4, 2021
Last Update Posted : February 4, 2021
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Condition or disease | Intervention/treatment | Phase |
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Inflammatory Bowel Diseases (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Phase 1 |
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. |
Actual Study Start Date : | March 2014 |
Actual Primary Completion Date : | September 30, 2016 |
Actual Study Completion Date : | September 30, 2016 |
Arm | Intervention/treatment |
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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
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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 |
- Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term [ Time Frame: 6 months ]Adverse events recorded to determine safety of Fecal Microbiome Transplant in the treatment of children with IBD.
- 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. [ Time Frame: Baseline, Day 30, Day 180 ]
Efficacy outcomes scored via Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis.
Scored at baseline, day 30, and at day 180 for responders.
The PUCAI score range is 0-85, where the higher the number the more severe the disease (A score of 65 and up is considered severe, a score of 35-64 is considered moderate, and a score of 10-34 is considered mild). The PUCAI is the scoring system used for patients with ulcerative colitis/indeterminate colitis.
The PCDAI score range is 0-100, where the higher the number the more severe the disease (A score of greater than 30 is considered moderate to severe, a score of 11-30 is considered mild, and a score of 10 or less is considered inactive disease). The PCDAI is the scoring system used for patients with crohn's disease.
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Ages Eligible for Study: | 2 Years to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Alka Goyal, MD | Stanford University |
Documents provided by Children's Mercy Hospital Kansas City:
Responsible Party: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT02108821 |
Other Study ID Numbers: |
PRO13030081 |
First Posted: | April 9, 2014 Key Record Dates |
Results First Posted: | February 4, 2021 |
Last Update Posted: | February 4, 2021 |
Last Verified: | February 2021 |
Inflammatory Bowel Diseases (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC) |
Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |