Crohn DiseaseOATSNCT04946448
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
A study testing FIT diet in people with Crohn Disease and Inflammatory Bowel Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy
- What is being tested?
- FIT diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Isolde Aerden contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Leuven
Leuven
João PG Sabino, MD PhD, 003216341770, joao.sabino@uzleuven.be
João PG Sabino, MD PhD
About this 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.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy
- Being tested
- FIT diet
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT dietOther
Dietary intervention as add-on therapy to biologicals
| Study group | Role | What they receive |
|---|---|---|
| FIT group | Experimental | Patients treated with biological treatment and the FIT diet Receives: Other: FIT diet |
| Control group | No intervention | Patients treated with biological treatment and the standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (10)
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
Measured: 6 months and 1 year
Clinical remission
PRO2≤8
Measured: 6 months and 1 year
Steroid-free clinical remission
PRO2≤8, no steroids
Measured: 6 months and 1 year
Endoscopic remission
SES-CD <2
Measured: 1 year
Endoscopic improvement
drop in SES-CD with at least 50%
Measured: 1 year
CRP improvement
50% or more improvement in CRP or CRP <5 mg/L
Measured: 6 months and 1 year
Fecal calprotectin improvement
50% or more improvement in faecal calprotectin or faecal calprotectin <250 µg/g
Measured: 6 months and 1 year
Number of participants without nutritional deficiencies
Absence of vitamin B12, vitamin D, folic acid, iron deficiencies
Measured: 6 months and 1 year
Fatigue
30% or more improvement in IBD Disk energy score
Measured: 6 months and 1 year
Health-related quality of life
30% or more improvement in overall IBD Disk score
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start14 Sep 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João PG Sabino, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946448
- Sponsor's protocol ID
- S64746
- Acronym
- OATS
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
- ClinicalTrials.gov ID
- NCT04946448
- Acronym / sponsor ID
- OATS / S64746
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT group | Experimental | Other: FIT dietPatients treated with biological treatment and the FIT diet |
| Control group | No intervention | –Patients treated with biological treatment and the standard diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Abcess,
- Bowel resection within 6 months before enrolment,
- Ostomy,
- Short-bowel syndrome,
- Clinically significant stricture that could require surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT dietDietary intervention as add-on therapy to biologicals | Other | FIT group |
Primary outcome
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.
10 secondary outcomes
Clinical response
Time frame: 6 months and 1 year
Clinical remission
Time frame: 6 months and 1 year
Steroid-free clinical remission
Time frame: 6 months and 1 year
Endoscopic remission
Time frame: 1 year
Endoscopic improvement
Time frame: 1 year
CRP improvement
Time frame: 6 months and 1 year
Fecal calprotectin improvement
Time frame: 6 months and 1 year
Number of participants without nutritional deficiencies
Time frame: 6 months and 1 year
Fatigue
Time frame: 6 months and 1 year
Health-related quality of life
Time frame: 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isolde Aerden contact
João PG Sabino, MD PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT diet in people with Crohn Disease and Inflammatory Bowel Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João PG Sabino, MD PhD (003216341770, joao.sabino@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-free clinical and biochemical remission (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.