We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04946448
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 14, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Steroid-free clinical and biochemical remission [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months and 1 year ]
    PRO2≤8

  3. Steroid-free clinical remission [ Time Frame: 6 months and 1 year ]
    PRO2≤8, no steroids

  4. Endoscopic remission [ Time Frame: 1 year ]
    SES-CD <2

  5. Endoscopic improvement [ Time Frame: 1 year ]
    drop in SES-CD with at least 50%

  6. CRP improvement [ Time Frame: 6 months and 1 year ]
    50% or more improvement in CRP or CRP <5 mg/L

  7. Fecal calprotectin improvement [ Time Frame: 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 [ Time Frame: 6 months and 1 year ]
    Absence of vitamin B12, vitamin D, folic acid, iron deficiencies

  9. Fatigue [ Time Frame: 6 months and 1 year ]
    30% or more improvement in IBD Disk energy score

  10. Health-related quality of life [ Time Frame: 6 months and 1 year ]
    30% or more improvement in overall IBD Disk score


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04946448


Contacts
Layout table for location contacts
Contact: João PG Sabino, MD PhD 003216341770 joao.sabino@uzleuven.be
Contact: Isolde Aerden isolde.aerden@uzleuven.be

Locations
Layout table for location information
Belgium
University Hospital of Leuven Recruiting
Leuven, Belgium
Contact: João PG Sabino, MD PhD    003216341770    joao.sabino@uzleuven.be   
Principal Investigator: João PG Sabino, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
Layout table for investigator information
Principal Investigator: João PG Sabino, MD PhD UZ Leuven
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT04946448    
Other Study ID Numbers: S64746
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases