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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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Other: Ulcerative Colitis Diet Drug: Antibiotic cocktail Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. Remission rate, defined as a PUCAI less than 10 at week 6. [ Time Frame: week 6 ]

Secondary Outcome Measures :
  1. Mean PUCAI week 6 [ Time Frame: week 6 ]
  2. Mean Calprotectin at week 6 [ Time Frame: week 6 ]
  3. Physicians Global Assessment week 6 [ Time Frame: week 6 ]
  4. Remission week 12, defined as a PUCAI less than 10 [ Time Frame: week 12 ]
  5. Mean PUCAI week 12 [ Time Frame: week 12 ]


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Ages Eligible for Study:   8 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02345733


Contacts
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Contact: Arie Levine, MD 972-3-5028838 arie.levine.dr@gmail.com
Contact: Chen Sarbagili 972-3-5028838 ibd.chen@gmail.com

Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lindsey Albenberg, MD    215-590-1680    albenbergl@chop.edu   
Principal Investigator: Lindsey Albenberg, MD         
Canada, Nova Scotia
IWK Health Centre, Dalhousie University Not yet recruiting
Halifax, Nova Scotia, Canada, 9700
Contact: Johan Van Limbergen, MD    (902) 470-8746/8225    Johanvanlimbergen@dal.ca   
Principal Investigator: Johan Van Limbergen, MD         
Israel
The E. Wolfson.Medical Center Recruiting
Holon, Israel, 58100
Contact: Arie Levine, MD    972-3-5028808    alevine@wolfson.health.gov.il   
Contact: Chen Sarbagili    972-3-5028838    ibd.chen@gmail.com   
Principal Investigator: Arie Levine, MD         
Sponsors and Collaborators
Prof. Arie Levine
Investigators
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Principal Investigator: Arie Levine, MD Wolfson Medical Center

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Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02345733     History of Changes
Other Study ID Numbers: 0009-15-WOMC
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
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
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents