We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02345733
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 1, 2022
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.

Layout table for study information
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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : October 29, 2021
Actual Study Completion Date : October 29, 2021

Resource links provided by the National Library of Medicine

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Layout table for location information
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Canada, Nova Scotia
IWK Health Centre, Dalhousie University
Halifax, Nova Scotia, Canada, 9700
The E. Wolfson.Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Prof. Arie Levine
Layout table for investigator information
Principal Investigator: Arie Levine, MD Wolfson Medical Center
Layout table for additonal information
Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02345733    
Other Study ID Numbers: 0009-15-WOMC
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents