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

Universitaire Ziekenhuizen KU Leuven144 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Crohn Disease Inflammatory Bowel Diseases Diet, Healthy

Interventions

FIT dietOTHER

Dietary intervention as add-on therapy to biologicals

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital of Leuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Month 6

Secondary Outcomes

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

Time frame: 6 months and 1 year

Clinical remission

PRO2≤8

Time frame: 6 months and 1 year

Steroid-free clinical remission

PRO2≤8, no steroids

Time frame: 6 months and 1 year

Endoscopic remission

SES-CD \<2

Time frame: 1 year

Endoscopic improvement

drop in SES-CD with at least 50%

Time frame: 1 year

CRP improvement

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

Time frame: 6 months and 1 year

Fecal calprotectin improvement

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

Time frame: 6 months and 1 year

Number of participants without nutritional deficiencies

Central Contacts

João PG Sabino, MD PhD

CONTACT

003216341770 joao.sabino@uzleuven.be

Isolde Aerden

CONTACT

isolde.aerden@uzleuven.be

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.