Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)

NCT03833596 | Terminated Phase 4

• 1 other identifier: EEN in Crohn
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of Exclusive Enteral Nutrition (EEN) in addition to different regimes of corticosteroid (CS) therapy (Prednisone) compared to CS alone in adults participants with active Crohn's Disease, on symptoms and inflammation after 6 weeks of treatment. Participants will be randomized to three treatment arms: standard CS, standard CS with EEN, short course CS with EEN. Participants will be assessed through questionnaires for gut symptoms, quality of life, mood changes and dietary patterns and potential mechanisms will be investigated by collecting stool samples for characterization of gut bacterial profiles, collection of blood to determine inflammatory markers and evaluation of gut motility before and after treatment. The investigators hypothesize that six weeks of EEN with CS will be more effective than CS alone in inducing clinical remission in patients with active CD, as well as leading to beneficial changes in the composition and/or metabolic activity of the intestinal microbiota, gastrointestinal transit and inflammatory burden. Furthermore, six weeks of EEN in addition to a short course of CS will have similar efficacy than EEN with standard course of CS and reduced number of adverse events.

Conditions

Crohn's Disease

Keywords

Corticosteroids; Exclusive Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index - CDAI<150) in adult patients with active CD (CDAI>220 and either CRP>5 or fecal calprotectin >250mg/l)

  Assess the efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index (CDAI)\<150) compared to treatment with CS alone in adult patients with active CD (CDAI\>220 and either CRP\>5 or fecal calprotectin \>250mg/l)

  2 years

Secondary Outcomes (9)

• Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement

  2 years

• Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life

  2 years

• Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission

  2 years

• Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit

  2 years

• Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores

  2 years

Study Arms (3)

Standard course CS with Regular Food

ACTIVE COMPARATOR

40 mg a day of oral Prednisone for 2 weeks with subsequent taper of daily dose by 5 mg per week.

Drug: Prednisone

Standard course CS with EEN

EXPERIMENTAL

40 mg a day of oral Prednisone for 2 weeks and taper of daily dose by 5 mg per week and Exclusive Enteral Nutrition for 6 weeks.

Drug: Prednisone; Dietary Supplement: Exclusive Enteral Nutrition

Short course CS with EEN

EXPERIMENTAL

40 mg a day of oral Prednisone for 3 days and taper of daily dose by 5 mg every 3 days and Exclusive Enteral Nutrition for 6 weeks.

Drug: Prednisone; Dietary Supplement: Exclusive Enteral Nutrition

Interventions

Prednisone DRUG

All 3 arms will receive Prednisone - 2 will be standard course treatment, 1 will be short course and rapidly-tapered

Short course CS with EEN; Standard course CS with EEN; Standard course CS with Regular Food

Exclusive Enteral Nutrition DIETARY_SUPPLEMENT

2 arms will receive EEN, in concurrence with either regular-course or short course and rapidly-tapered CS.

Also known as: Modulen (Nestlé)

Short course CS with EEN; Standard course CS with EEN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed CD for at least 6 months
• Clinically active disease (CDAI \>220 or Harvey-Bradshaw Index (HBI) \>6) or active by endoscopy.
• Biochemical evidence of disease activity (CRP \>5 and/or fecal calprotectin \>250)

You may not qualify if:

• Currently using EEN
• Condition that would preclude the use of EEN, such as Intestinal obstruction, perforation, toxic megacolon, massive gastrointestinal bleeding, abdominal abscess, or stricturing disease
• Previous intestinal resection with a remnant bowel of less than 180 cm
• Treatment with Prednisone in the last 30 days
• New start or change in dose of azathioprine, 6-mercaptopurine, cyclosporine, other immunosuppressant or biologics in the last 90 days. Doses of these medications must also remain unchanged for the duration of the study
• New start or change in dose of 5-aminosalicylic acid (ASA) in the last 30 days. 5ASA dose must remain unchanged for the duration of the study
• Use of Antibiotics or Probiotics in the last 30 days
• Pregnant or Lactating
• Any serious illness which could interfere with study procedures or results

Sponsors & Collaborators

• McMaster University: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

McMaster University

Hamilton, on, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Maria I Pinto-Sanchez, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment options are randomized and masked for participants and study staff until Visit 2, where participants and investigators are made aware of treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine

Model Details: Randomized control trial with three arms of treatment: EEN plus standard or short course of CS versus CS alone.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: February 7, 2019
• Study Start: October 25, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 2, 2020

Record last verified: 2019-02

Locations

CA (1)