K50
Conditions
Interventions
Group 1: Modulen® IBD, ca. 500ml orally daily, for 1 Year as an oral nutritional supplement
Group 2: Control group without nutritional intervention
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Diagnosis of CD, age 6 – 18 y , in clinical remission or with mild disease activity (weighted PCDAI = 40), on stable medical treatment, signed consent form obtained by guardians and ascent of participants
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have undergone a major surgical resection of the small or large bowel (>20 cm), have cow’s milk protein allergy, have other chronic disease (liver, heart, renal etc.), have been treated with systemic corticosteroid, exclusive enteral nutrition, growth hormone or anabolic steroids in the last 3 months and/or require therapy intensification at the inclusion visit, or had bone density examination (DXA or pQCT) within 12 months prior to invitation to study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in z-score cross sectional muscle area at the non-dominant forearm at baseline and after one year using pQCT (peripheral quantitative computed tomography). We hypothesise an increase in cross sectional muscle area of +0.5 z-scores in the intervention group compared to controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement in bone density and structure (increase in trabecular density, normalization of usually high cortical density, change in cross sectional bone areas) measured by pQCT on the non-dominant forearm prior to study beginn and after one year - improvement in anthropometric parameters (weight, height, BMI z-scores) assessed every 3 months, - improvement of inflammatory parameters in the blood assessed every 3 months, - improvement in metabolomic markers on growth, body composition and nutritional status assessed in plasma every 3 months, - changes in microbiota profile assessed by high-throughput 16S ribosomal RNA (rRNA) amplicon gene sequencing, stool collection every 3 months, - change in disease activity resp. duration of remission at 6 months and 1 year follow-up using the mathematically weighted pediatric Crohn´s disease activity index - change in quality of life using a validated questionaire every 6 months of patients in the ONS treated (intervention) group in comparison to patients in the non-intervention group | — |
Countries
Germany
Contacts
Public ContactKlara Frivolt
Klinikum der Universität München, Campus Innenstadt, Dr. von Haunersches Kinderspital, Abteilung für Gastroenterologie & Hepatologie
Outcome results
None listed