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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 8 Years - 19 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02345733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Arie Levine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Arie Levine, MD
Principal Investigator Affiliation Wolfson Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, Israel, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis (UC)
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Lindsey Albenberg, MD

albenbergl@chop.edu

215-590-1680

International Sites

IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada

Status

Not yet recruiting

Address

IWK Health Centre, Dalhousie University

Halifax, Nova Scotia, 9700

Site Contact

Johan Van Limbergen, MD

Johanvanlimbergen@dal.ca

(902) 470-8746/8225

The E. Wolfson.Medical Center, Holon, Israel

Status

Recruiting

Address

The E. Wolfson.Medical Center

Holon, , 58100

Site Contact

Arie Levine, MD

alevine@wolfson.health.gov.il

972-3-5028808

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