COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

NCT04946448 | Recruiting DMC

• 1 other identifier: S64746
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Diet, Healthy

Outcome Measures

Primary Outcomes (1)

• Steroid-free clinical and biochemical remission

  Normalization of faecal calprotectin (\< 250 µg/g) and steroid-free clinical remission, defined as patient PRO2 ≤ 8 (average daily stool frequency ≤ 1.5 AND average daily abdominal pain score ≤ 1), at month 6.

  Month 6

Secondary Outcomes (10)

• Clinical response

  6 months and 1 year

• Clinical remission

  6 months and 1 year

• Steroid-free clinical remission

  6 months and 1 year

• Endoscopic remission

  1 year

• Endoscopic improvement

  1 year

Study Arms (2)

FIT group

EXPERIMENTAL

Patients treated with biological treatment and the FIT diet

Other: FIT diet

Control group

NO INTERVENTION

Patients treated with biological treatment and the standard diet

Interventions

FIT diet OTHER

Dietary intervention as add-on therapy to biologicals

FIT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-80 years)
• active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
• patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) \> 8,
• faecal calprotectin above 250 µg/g.

You may not qualify if:

• Abcess,
• Bowel resection within 6 months before enrolment,
• Ostomy,
• Short-bowel syndrome,
• Clinically significant stricture that could require surgery,
• Pregnant,
• Lactating woman or desire to become pregnant during the study,
• Unwilling or unable to follow the study diet.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital of Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• João PG Sabino, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João PG Sabino, MD PhD

CONTACT

003216341770; joao.sabino@uzleuven.be

Isolde Aerden

CONTACT

isolde.aerden@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 30, 2021
• Study Start: September 14, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)