Use of the Ulcerative Colitis Diet for Induction of Remission

NCT02217722 | Terminated DMC

• 1 other identifier: 0096-14-WOMC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.

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 (2)

• Change in Mean PUCAI week 6.

  week 6

• Change in mean Calprotectin week 6

  week 6

Study Arms (2)

Ulcerative Colitis Diet counseling

EXPERIMENTAL

Patients will receive a structured novel diet termed the UCD for 6 weeks. . patients that completed induction phase with remission(PUCAI\<10) will be asked if they are willing to adhere to the UCD for an additional 20 weeks.

Other: Ulcerative Colitis Diet

Antibiotic Treatment

EXPERIMENTAL

Patients failing to enter or maintain remission by 6 weeks, or with worsening disease at any time after week 2 will be considered failures on an intention to treat basis. Eligible patients at this time at aged 10 or above may receive a 14 day antibiotic course with Doxycycline, amoxicillin and metronidazole.In addition to the description above children who refused to UCD or with low adherence to UCD may be enrolled directly to this arm.

Drug: Antibiotic cocktail

Interventions

Ulcerative Colitis Diet OTHER

we have postulated that a diet that increases butyrate through fiber exposure, reduces intestinal sulfur exposure, and increases vitamin D levels could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.

Ulcerative Colitis Diet counseling

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

You may qualify if:

• Informed consent
• Established diagnosis of UC disease.
• Age: 5 - 18 years ( inclusive)
• Mild to moderate active disease, 10 ≤ PUCAI ≤45.
• Stable medication (IMM/ 5ASA) use for the past 6 weeks.
• For patients who received antibiotic treatment: age 10-18 (inclusive).

You may not qualify if:

• Any proven infection such as positive stool culture, parasite or C.difficile.
• Use of Antibiotics
• Use of steroids in the previous two weeks only
• Patients that are refractory to full dose steroids ( 1 mg/kg/day)
• Past acute severe UC.
• Current Extra intestinal manifestation of UC.
• Pregnancy.
• A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study.

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (1)

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 Design

• Study Type: interventional
• Phase: not applicable
• 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: July 20, 2014
• First Posted: August 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

IL (1)