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Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02345733
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

Tracking Information
First Submitted Date  ICMJE January 19, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date October 17, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
Remission rate, defined as a PUCAI less than 10 at week 6. [ Time Frame: week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02345733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Mean PUCAI week 6 [ Time Frame: week 6 ]
  • Mean Calprotectin at week 6 [ Time Frame: week 6 ]
  • Physicians Global Assessment week 6 [ Time Frame: week 6 ]
  • Remission week 12, defined as a PUCAI less than 10 [ Time Frame: week 12 ]
  • Mean PUCAI week 12 [ Time Frame: week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
  • Mean PUCAI week 6 [ Time Frame: week 6 ]
  • Mean Calprotectin at week 6 [ Time Frame: week 6 ]
  • Physicians Global Assessment week 6 [ Time Frame: week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis
Official Title  ICMJE Use of a Novel Diet (UC DIET) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study
Brief Summary The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression.
Detailed Description

Ulcerative colitis is a chronic inflammatory disease primarily involving the colon. It has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors . Recent studies have highlighted several characteristics which may suggest that UC is associated with alterations of the microbiota, defective production of short chain fatty acids and an impaired mucous layer. However at present, no effective therapy targets the microbiota or its interaction with the colonic epithelium. UC in humans is characterized by increased mucosal sulfides and increased sulfate and sulfide reducing bacteria and activation of amino acid metabolism pathways which impair butyrate production, whereas certain dietary patterns in humans and rodent models may induce dysbiosis and favor sulphide reducing bacteria. Further support for targeting the microbiota includes several studies demonstrating that antibiotics might be helpful for severe refractory colitis. Development of treatment strategies that target the microbiota could reduce exposure to immune suppression, and add new therapeutic strategies that do not exist at present.

Though diet has a significant impact on the composition of the microbiota no dietary intervention to date has proven effective for induction of remission. The investigators hypothesized that ulcerative colitis is caused by a series of events involving dysbiosis with sulfate or sulfide reducing bacteria combined with defective production of short chain fatty acids, coupled with a defective mucous layer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis (UC)
Intervention  ICMJE
  • Other: Ulcerative Colitis Diet
    we have postulated that a diet that we developed that reduces exposure to dietary ingredients that allow sulfide reducing bacteria to thrive, or that impair the mucous layer, coupled with dietary products that enhance butyrate production, could induce remission in UC without involving additional immune suppression.
  • Drug: Antibiotic cocktail
    We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
    Other Name: •Doxycyclin, amoxicillin and metronidazole
Study Arms  ICMJE
  • Experimental: Ulcerative Colitis Diet
    Patients will receive a structured novel diet termed the UCD for 6 weeks, and those in remission at week 6 will receive the step down diet for another 6 weeks.
    Intervention: Other: Ulcerative Colitis Diet
  • Experimental: Antibiotic Treatment
    This antibiotic treatment will be given as an open label for patients who refuse diet therapy or for patients who show no improvement by week 3 , deteriorate by week 6, or patients who are not in full remission by week 6 will receive a 14 day course of antibiotics as previously described by Kato and colleagues.
    Intervention: Drug: Antibiotic cocktail
Publications * Not Provided

*   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: January 23, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent
  2. Established diagnosis of UC.
  3. Age: 8 - 19 years ( inclusive)
  4. Mild to moderate active disease, 10 ≤ PUCAI ≤45.
  5. Stable medication (IMM/ 5ASA) use for the past 6 weeks. Patients who have received topical 5ASA therapy for <7 days and are active may be included if topical therapy is stopped at enrolment

Exclusion Criteria:

Exclusion criteria:

  1. Any proven current infection such as positive stool culture, parasite or C. difficile.
  2. Antibiotic or Steroids use in the past 2 weeks.
  3. PUCAI >45
  4. Acute severe UC in the previous 12 months.
  5. Current Extra intestinal manifestation of UC.
  6. PSC or Liver disease
  7. Pregnancy.
  8. Allergy to one of the antibiotics or age <11 will exclude patients from entering the antibiotic arm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arie Levine, MD 972-3-5028838 arie.levine.dr@gmail.com
Contact: Chen Sarbagili 972-3-5028838 ibd.chen@gmail.com
Listed Location Countries  ICMJE Canada,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02345733
Other Study ID Numbers  ICMJE 0009-15-WOMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Arie Levine, Wolfson Medical Center
Study Sponsor  ICMJE Prof. Arie Levine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arie Levine, MD Wolfson Medical Center
PRS Account Wolfson Medical Center
Verification Date October 2018

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