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NCT Number: NCT04946448

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

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.

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Key information

Conditions

Crohn Disease Diet, Healthy Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Leuven

Leuven, Belgium

Location status: Recruiting

Location contact

João PG Sabino, MD PhD

CONTACT

[email protected]

003216341770

João PG Sabino, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FIT diet

Other

Dietary intervention as add-on therapy to biologicals

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Isolde Aerden

CONTACT

[email protected]

João PG Sabino, MD PhD

CONTACT

[email protected]

003216341770

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: OATS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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