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

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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

Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 30, 2021
Last Update Posted Date September 30, 2021
Actual Study Start Date  ICMJE September 14, 2021
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2021)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2021)
  • 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
  • Clinical remission [ Time Frame: 6 months and 1 year ]
    PRO2≤8
  • Steroid-free clinical remission [ Time Frame: 6 months and 1 year ]
    PRO2≤8, no steroids
  • Endoscopic remission [ Time Frame: 1 year ]
    SES-CD <2
  • Endoscopic improvement [ Time Frame: 1 year ]
    drop in SES-CD with at least 50%
  • CRP improvement [ Time Frame: 6 months and 1 year ]
    50% or more improvement in CRP or CRP <5 mg/L
  • Fecal calprotectin improvement [ Time Frame: 6 months and 1 year ]
    50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g
  • Number of participants without nutritional deficiencies [ Time Frame: 6 months and 1 year ]
    Absence of vitamin B12, vitamin D, folic acid, iron deficiencies
  • Fatigue [ Time Frame: 6 months and 1 year ]
    30% or more improvement in IBD Disk energy score
  • Health-related quality of life [ Time Frame: 6 months and 1 year ]
    30% or more improvement in overall IBD Disk score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Official Title  ICMJE COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Diet, Healthy
Intervention  ICMJE Other: FIT diet
Dietary intervention as add-on therapy to biologicals
Study Arms  ICMJE
  • Experimental: FIT group
    Patients treated with biological treatment and the FIT diet
    Intervention: Other: FIT diet
  • No Intervention: Control group
    Patients treated with biological treatment and the standard diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2021)		 144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: João PG Sabino, MD PhD 003216341770 joao.sabino@uzleuven.be
Contact: Isolde Aerden isolde.aerden@uzleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04946448
Other Study ID Numbers  ICMJE S64746
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Universitaire Ziekenhuizen KU Leuven
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universitaire Ziekenhuizen KU Leuven
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: João PG Sabino, MD PhD UZ Leuven
PRS Account Universitaire Ziekenhuizen KU Leuven
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP