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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04946448
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitaire Ziekenhuizen KU Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

João PG Sabino, MD PhD
Principal Investigator Affiliation UZ Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy
Arms & Interventions

Arms

Experimental: FIT group

Patients treated with biological treatment and the FIT diet

No Intervention: Control group

Patients treated with biological treatment and the standard diet

Interventions

Other: - FIT diet

Dietary intervention as add-on therapy to biologicals

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital of Leuven, Leuven, Belgium

Status

Recruiting

Address

University Hospital of Leuven

Leuven, ,

Site Contact

João PG Sabino, MD PhD

joao.sabino@uzleuven.be

003216341770