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The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis (FMT_UC)

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ClinicalTrials.gov Identifier: NCT02291523
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sonia Michail, MD, Children's Hospital Los Angeles

Brief Summary:
Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: Fecal Microbial Transplant Phase 1

Detailed Description:
The enteric microbiota is now accepted as an important etiologic factor in the pathogenesis of human Inflammatory Bowel Disease (IBD) and immune-mediated chronic experimental intestinal inflammation, with ample data to implicate the microbiome as a main factor in the occurrence of IBD. This can be inferred from animals in germ-free environment which can protect from experimental colitis. In addition, increased gut permeability due to dysbiosis, is frequently seen in patients with IBD even in remission and, similarly, first degree relatives of IBD. Therefore, it is not surprising that therapeutic interventions aiming at modifying the gut microbiome would be of therapeutic benefit. Ulcerative colitis is a condition that is characterized by chronic inflammation of the colon. It is an important pediatric disease as 25% of all cases begin in childhood and its incidence is continuously on the rise. It is believed to be related to a genetically and environmentally-generated altered immune response to the enteric microbiome. Previous work in the PI's laboratory suggests that children harbor a unique gut microbial profile, which can predict therapeutic response. Therefore, modifying the gut microbiome may result in therapeutic benefit. However, attempts to modify the gut microbiome were largely unsuccessful until the advent of fecal transplant, which is a new approach in treating colitis. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance and it appears to be a more efficient method to effectively change and sustain the gut microbial composition. To date there have been a number of successful reports to suggest control of disease activity and in some cases cure of the disease. This study aims to further determine the safety and efficacy of FMT in treating children with ulcerative colitis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis
Study Start Date : November 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Patient Stool Transplant
Arm 1 will get FMT (Fecal Microbial Transplant) placebo and high dose 5-ASA (Pentasa). The FMT is done through colonoscopy.
Biological: Fecal Microbial Transplant
Fecal Transplant via Colonoscopy.
Other Name: FMT

Active Comparator: Donor Stool Transplant
Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool and high dose 5-ASA (Pentasa). The FMT is done through colonoscopy.
Biological: Fecal Microbial Transplant
Fecal Transplant via Colonoscopy.
Other Name: FMT




Primary Outcome Measures :
  1. The primary endpoint is disease remission based on PUCAI scores (<10). [ Time Frame: 12 Months ]
    The primary outcome including results of disease activity, and safety measures.


Secondary Outcome Measures :
  1. Secondary endpoints will include change in mucosal inflammation reflected on laboratory studies. [ Time Frame: 12 Months ]
    Secondary endpoints include changes in gut microbial diversity - determined by gut microbial genomics and proteomics, and outcome measures for mucosal inflammation and repair including laboratory testing such as the level for C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as well as the stool calprotectin level.



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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Age: 7-21 who have been diagnosed with ulcerative colitis
  2. Mild to moderate disease based on PUCAI with a score of 10-64
  3. Need for colonoscopy

Exclusion Criteria

  1. Children who are known to be resistant to steroid therapy, immunomodulators and biologics, or on a steroid dose greater than 0.5 mg/kg/day (maximum 20 mg)
  2. Children with recent dose change of biologics (within 4 weeks), 5-ASA, steroids or immunomodulators (within 4 weeks)
  3. Allergy to or intolerance of mesalamine or 5-ASA products
  4. Any evidence of infectious colitis
  5. Concurrent infections that require anti-microbial therapy (such as abdominal abscess, pneumonia, etc…)
  6. Unable to give informed consent/assent
  7. Have received probiotic preparations ≤ 4 weeks prior to randomization
  8. Pregnancy and breast feeding in patient subjects of childbearing potential
  9. Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct bilirubin > 2 mg/dl), Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due to conditions other than ulcerative colitis (such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.

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): NCT02291523


Contacts
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Contact: Sonia Michail, MD 323-361-1353 sonia.michail@hotmail.com

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sonia Michail, MD    323-361-1353    sonia.michail@hotmail.com   
Contact: Roy Leong, CCRP    323-361-7877    rleong@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Sonia Michail, MD Children Hospital Los Angeles

Publications:
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Responsible Party: Sonia Michail, MD, Professor of Clinical Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02291523     History of Changes
Other Study ID Numbers: CHLA-16-00050
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sonia Michail, MD, Children's Hospital Los Angeles:
Fecal transplant
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases