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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

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date January 30, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02291523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis
Official Title  ICMJE The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Biological: Fecal Microbial Transplant
Fecal Transplant via Colonoscopy.
Other Name: FMT
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Fecal Microbial Transplant
  • 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.
    Intervention: Biological: Fecal Microbial Transplant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
101
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
96
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sonia Michail, MD 323-361-1353 sonia.michail@hotmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291523
Other Study ID Numbers  ICMJE CHLA-16-00050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sonia Michail, MD, Children's Hospital Los Angeles
Study Sponsor  ICMJE Children's Hospital Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sonia Michail, MD Children Hospital Los Angeles
PRS Account Children's Hospital Los Angeles
Verification Date January 2019

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