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

Crohn Disease Clinical Trial

— OATS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946448
• Other study ID #: S64746
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: João PG Sabino, MD PhD
• Phone: 003216341770
• Email: joao.sabino[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Diet, Healthy
• Inflammatory Bowel Diseases

Intervention

Other:
• FIT diet
Dietary intervention as add-on therapy to biologicals

Locations

Country	Name	City	State
Belgium	University Hospital of Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical remission	PRO2=8	6 months and 1 year
Secondary	Steroid-free clinical remission	PRO2=8, no steroids	6 months and 1 year
Secondary	Endoscopic remission	SES-CD <2	1 year
Secondary	Endoscopic improvement	drop in SES-CD with at least 50%	1 year
Secondary	CRP improvement	50% or more improvement in CRP or CRP <5 mg/L	6 months and 1 year
Secondary	Fecal calprotectin improvement	50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g	6 months and 1 year
Secondary	Number of participants without nutritional deficiencies	Absence of vitamin B12, vitamin D, folic acid, iron deficiencies	6 months and 1 year
Secondary	Fatigue	30% or more improvement in IBD Disk energy score	6 months and 1 year
Secondary	Health-related quality of life	30% or more improvement in overall IBD Disk score	6 months and 1 year