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

NCT02345733 | Completed Phase 4

• 1 other identifier: 0009-15-WOMC
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Remission rate, defined as a PUCAI less than 10 at week 6.

  week 6

Secondary Outcomes (5)

• Mean PUCAI week 6

  week 6

• Mean Calprotectin at week 6

  week 6

• Physicians Global Assessment week 6

  week 6

• Remission week 12, defined as a PUCAI less than 10

  week 12

• Mean PUCAI week 12

  week 12

Study Arms (2)

Ulcerative Colitis Diet

EXPERIMENTAL

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

Antibiotic Treatment

EXPERIMENTAL

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

Interventions

Ulcerative Colitis Diet OTHER

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.

Ulcerative Colitis Diet

Antibiotic cocktail DRUG

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

Also known as: •Doxycyclin, amoxicillin and metronidazole

Antibiotic Treatment

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent
• Established diagnosis of UC.
• Age: 8 - 19 years ( inclusive)
• Mild to moderate active disease, 10 ≤ PUCAI ≤45.
• 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

You may not qualify if:

• Any proven current infection such as positive stool culture, parasite or C. difficile.
• Antibiotic or Steroids use in the past 2 weeks.
• PUCAI \>45
• Acute severe UC in the previous 12 months.
• Current Extra intestinal manifestation of UC.
• PSC or Liver disease
• Pregnancy.
• Allergy to one of the antibiotics or age \<11 will exclude patients from entering the antibiotic arm

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (3)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

IWK Health Centre, Dalhousie University

Halifax, Nova Scotia, 9700, Canada

Location

The E. Wolfson.Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Doxycycline; Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Arie Levine, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and Nutrition unit.

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: September 1, 2015
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CA (1); IL (1); US (1)