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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04946448
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease; Inflammatory Bowel Diseases; Diet, Healthy	Other: FIT diet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
• Actual Study Start Date: Sep 14, 2021
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Steroid-free clinical and biochemical remission [Month 6]

   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.

Secondary Outcome Measures

1. Clinical response [6 months and 1 year]

   ≥ 30% decrease in average daily stool frequency and/or ≥ 30% decrease in average daily abdominal pain score and both not worse than baseline

2. Clinical remission [6 months and 1 year]

   PRO2≤8

3. Steroid-free clinical remission [6 months and 1 year]

   PRO2≤8, no steroids

4. Endoscopic remission [1 year]

   SES-CD <2

5. Endoscopic improvement [1 year]

   drop in SES-CD with at least 50%

6. CRP improvement [6 months and 1 year]

   50% or more improvement in CRP or CRP <5 mg/L

7. Fecal calprotectin improvement [6 months and 1 year]

   50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g

8. Number of participants without nutritional deficiencies [6 months and 1 year]

   Absence of vitamin B12, vitamin D, folic acid, iron deficiencies

9. Fatigue [6 months and 1 year]

   30% or more improvement in IBD Disk energy score

10. Health-related quality of life [6 months and 1 year]

    30% or more improvement in overall IBD Disk score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Leuven	Leuven		Belgium

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: João PG Sabino, MD PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04946448
• Other Study ID Numbers: S64746
• First Posted: Jun 30, 2021
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; Inflammatory Bowel Diseases

Study Results

No Results Posted as of Sep 30, 2021