Effect of a low-dose enzyme together with a dietary supplement on nutrient absorption in patients at risk of malnutrition.

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06826105 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Effect of low dose pancrelipase with an oral nutritional supplement to improve nutrient bioavailability in patients at increased risk of malnutrition (BASEC)

Wissenschaftlicher Titel
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition (ICTRP)

Öffentlicher Titel
Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO) (ICTRP)

Untersuchte Krankheit(en)

Malnutrition

(ICTRP)

Untersuchte Intervention

Drug: ZenpepDrug: Placebo

(ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign

Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

(ICTRP)

Ein-/Ausschlusskriterien

Inclusion Criteria:

• Informed Consent as documented by signature
• Male or female 70 years of age or older
• Hospitalized at site
• Nutrition Risk Screening 2002 (NRS-2002) = 3
• eGFR = 30 mL/min/1.73 m2 (EPI-CKD) based on medical history (no older than 6 months)
• Ability to eat orally

Exclusion Criteria:

• Patients with acute cardiovascular event = 2 days
• Patients with terminal conditions
• Patients diagnosed with pancreatic exocrine insufficiency (EPI) treated with pancreatic enzyme replacement therapy (PERT)
• Patients having a planned transplant or new-onset dialysis in the next 6 months.
• Patients having a colectomy, resection of the small intestine or cholecystectomy
• Known hypersensitivity to any of the substances or excipients of the ONS or the medicinal product

(ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte

Incremental area under the curve of total branched-chained amino acid concentration

(ICTRP)

Incremental area under the curve of essential amino acids (EAAs);Incremental area under the curve of total amino acids;Incremental area under the curve of free fatty acids;Incremental area under the curve of triglycerides;Water load satiety test (WLST);Exploratory subgroup analysis;Incremental area under the curve of glucose

(ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Philipp Schuetz, Prof. MDPhilipp Schuetz, Prof. MDPhilipp Schuetz, Prof. MD, philipp.schuetz@ksa.chphilipp.schuetz@ksa.ch, +41 62 838 68 80+41 62 838 68 80, Kantonsspital Aarau (ICTRP)

Sekundäre IDs
2024-02519, ka24Schuetz (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06826105 (ICTRP)