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

Primary Purpose

Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FIT diet
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FIT group

Control group

Arm Description

Patients treated with biological treatment and the FIT diet

Patients treated with biological treatment and the standard diet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Clinical remission
PRO2≤8
Steroid-free clinical remission
PRO2≤8, no steroids
Endoscopic remission
SES-CD <2
Endoscopic improvement
drop in SES-CD with at least 50%
CRP improvement
50% or more improvement in CRP or CRP <5 mg/L
Fecal calprotectin improvement
50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g
Number of participants without nutritional deficiencies
Absence of vitamin B12, vitamin D, folic acid, iron deficiencies
Fatigue
30% or more improvement in IBD Disk energy score
Health-related quality of life
30% or more improvement in overall IBD Disk score

Full Information

First Posted
June 18, 2021
Last Updated
September 29, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04946448
Brief Title
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Acronym
OATS
Official Title
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIT group
Arm Type
Experimental
Arm Description
Patients treated with biological treatment and the FIT diet
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients treated with biological treatment and the standard diet
Intervention Type
Other
Intervention Name(s)
FIT diet
Intervention Description
Dietary intervention as add-on therapy to biologicals
Primary Outcome Measure Information:
Title
Steroid-free clinical and biochemical remission
Description
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 Outcome Measure Information:
Title
Clinical response
Description
≥ 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
Title
Clinical remission
Description
PRO2≤8
Time Frame
6 months and 1 year
Title
Steroid-free clinical remission
Description
PRO2≤8, no steroids
Time Frame
6 months and 1 year
Title
Endoscopic remission
Description
SES-CD <2
Time Frame
1 year
Title
Endoscopic improvement
Description
drop in SES-CD with at least 50%
Time Frame
1 year
Title
CRP improvement
Description
50% or more improvement in CRP or CRP <5 mg/L
Time Frame
6 months and 1 year
Title
Fecal calprotectin improvement
Description
50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g
Time Frame
6 months and 1 year
Title
Number of participants without nutritional deficiencies
Description
Absence of vitamin B12, vitamin D, folic acid, iron deficiencies
Time Frame
6 months and 1 year
Title
Fatigue
Description
30% or more improvement in IBD Disk energy score
Time Frame
6 months and 1 year
Title
Health-related quality of life
Description
30% or more improvement in overall IBD Disk score
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João PG Sabino, MD PhD
Phone
003216341770
Email
joao.sabino@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Isolde Aerden
Email
isolde.aerden@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João PG Sabino, MD PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João PG Sabino, MD PhD
Phone
003216341770
Email
joao.sabino@uzleuven.be
First Name & Middle Initial & Last Name & Degree
João PG Sabino, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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