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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Diet, Healthy
• Intervention / Treatment: Other: FIT diet

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: João PG Sabino, MD PhD; Phone Number: 003216341770; Email: joao.sabino@uzleuven.be
• Study Contact Backup: Name: Isolde Aerden; Email: isolde.aerden@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • University Hospital of Leuven
    • Contact: João PG Sabino, MD PhD; Phone Number: 003216341770; Email: joao.sabino@uzleuven.be
    • Principal Investigator: João PG Sabino, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIT group; Patients treated with biological treatment and the FIT diet	Other: FIT diet; Dietary intervention as add-on therapy to biologicals
No Intervention: Control group; Patients treated with biological treatment and the standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	≥ 30% decrease in average daily stool frequency and/or ≥ 30% decrease in average daily abdominal pain score and both not worse than baseline	6 months and 1 year
Clinical remission	PRO2≤8	6 months and 1 year
Steroid-free clinical remission	PRO2≤8, no steroids	6 months and 1 year
Endoscopic remission	SES-CD <2	1 year
Endoscopic improvement	drop in SES-CD with at least 50%	1 year
CRP improvement	50% or more improvement in CRP or CRP <5 mg/L	6 months and 1 year
Fecal calprotectin improvement	50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g	6 months and 1 year
Number of participants without nutritional deficiencies	Absence of vitamin B12, vitamin D, folic acid, iron deficiencies	6 months and 1 year
Fatigue	30% or more improvement in IBD Disk energy score	6 months and 1 year
Health-related quality of life	30% or more improvement in overall IBD Disk score	6 months and 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: João PG Sabino, MD PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: S64746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No