We aim to assess the feasability of a nutritional intervention as add-on treatment (next to standard medical treatment) in patients with IBD in remission. We will measure the effect of the nutritional intervention on symptoms, quality of life and…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We aim to assess the feasability of a nutritional intervention as add-on
treatment (next to standard medical treatment) in patients with IBD in
remission
Secondary outcome
Secondary objectives are to study the effect of the nutritional intervention
program on:
1. Quality of life and Food related quality of life (FR-QoL)
2. Activity of IBD (as assessed using Harvey-Bradshaw index (HBI) or partial
Mayo score (pMS) and fecal calprotectin)
3. Nutritional status and anthropometry (body weight, hand grip strength,
waist-hip ratio)
4. CAP value (Fibroscan; liver fat content)
5. Immunological assessment of Th17/Treg balance in the peripheral blood of
patients to assess effect of our lifestyle intervention program on the
pro-inflammatory / anti-inflammatory balance in the peripheral blood of patients
And in a subset of patients:
6. AGE reader
Background summary
Diet is important to patients with IBD (consisting of Crohn*s disease and
ulcerative colitis) and many patients ask whether eating the right foods can
make a difference for their disease. Although studies about diet and IBD are
conflicting, chronic inflammation, impaired intestinal barrier function and
microbial disturbances seen in IBD may be reduced by an anti-inflammatory diet.
We propose to investigate a nutritional intervention that combines
foods and nutrients with proven or plausible anti-inflammatory properties
Study objective
We aim to assess the feasability of a nutritional intervention as add-on
treatment (next to standard medical treatment) in patients with IBD in
remission. We will measure the effect of the nutritional intervention on
symptoms, quality of life and serum markers of inflammation.
Study design
Open label intervention pilot study to test the efficacy of using a nutritional
intervention as add-on treatment in patients with IBD in remission.
Intervention
Patients will enter a nutritional intervention program, coordinated by
Stichting voeding leeft. Control subjects will continue their regular diet.
Study burden and risks
The nutritional intervention program consists of group sessions (syllabus added
to the dossier for the METC), advising and educating patients about a
plant-based diet.
As a novel add on therapy for IBD in remission, it represents a safe approach
which has expected general health benefits, such as reducing the risks for
developing NAFLD and cardiovascular diseases in patients that would change
their lifestyle for a prolonged period.
en extra amount of blood will be drawn and stored.
albinusdreef 2
Leiden 233ZA
NL
albinusdreef 2
Leiden 233ZA
NL
Listed location countries
Age
Inclusion criteria
All patients with IBD in remission (fecal calprotectin (fCAL) < 150 mg/g and SES-CD<5, or MAYO score <1) are eligible to participate.
Exclusion criteria
Patients unable or unwilling to provide informed consent. Stenosis associated with symptoms. Current healthy lifestyle (as there will be nothing to optimize using our nutritional intervention program).
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63643.058.17 |