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Introduction of a Diet as add-on therapy for remission maintenance in IBD

Conditions
crohns disease
inflammatory bowel disease
ulcerative colitis
10017969
Registration Number
NL-OMON46767
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
80
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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>We aim to assess the feasability of a nutritional intervention as add-on<br /><br>treatment (next to standard medical treatment) in patients with IBD in<br /><br>remission</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary objectives are to study the effect of the nutritional intervention<br /><br>program on:<br /><br>1. Quality of life and Food related quality of life (FR-QoL)<br /><br>2. Activity of IBD (as assessed using Harvey-Bradshaw index (HBI) or partial<br /><br>Mayo score (pMS) and fecal calprotectin)<br /><br>3. Nutritional status and anthropometry (body weight, hand grip strength,<br /><br>waist-hip ratio)<br /><br>4. CAP value (Fibroscan; liver fat content)<br /><br>5. Immunological assessment of Th17/Treg balance in the peripheral blood of<br /><br>patients to assess effect of our lifestyle intervention program on the<br /><br>pro-inflammatory / anti-inflammatory balance in the peripheral blood of patients<br /><br>And in a subset of patients:<br /><br>6. AGE reader</p><br>
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