Influence of a formula enriched with resistant starch for exclusive enteral nutrition in children with acute Crohn's disease on selected butyrate-producing bacteria of the intestinal microbiome and inflammation

Influence of a formula enriched with resistant starch for exclusive enteral nutrition in children with acute Crohn's disease on selected butyrate-producing bacteria of the intestinal microbiome and inflammation - CEDRS01-McResi

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036031

Enrollment

128

Registered

2025-02-26

Start date

2026-04-07

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50

Interventions

Group 1: Interventiongroup, ecxclusive enteral nutrition with formula with resistant starch with the duration of 8 weeks Group 2: Interventiongroup, ecxclusive enteral nutrition with formula without r

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Crohn's disease according to Porto criteria Acute relapse (PCDAI > 30) Luminal disease Use of an immunosuppressant (azathioprine or methotrexate) informed consent from the patient and legal guardians

Exclusion criteria

Exclusion criteria: Remission (PCDAI < 11) Ileus, perforations, tumours, fistulas Perianal disease Bacterial / viral infections Pregnancy Medication with glucocorticoids, antibiotics, TNF-a antibodies, tacrolimus or cyclosporine Known intolerance to the components of the formula Participation in other intervention studies

Design outcomes

Primary

Measure	Time frame
Induction of remission, Pediatric Crohn's Disease Activity Index (PCDAI) < 11	—

Secondary

Measure	Time frame
Reduction of inflammatory markers CRP and FC Stabilisation / increase in body weight Improvement of the microbiome	—

Countries

Germany

Contacts

Public ContactJan deLaffolie

Universitätsklinikum Gießen

Jan.DeLaffolie@paediat.med.uni-giessen.de+49 (0)641 - 985 43521

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026