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

Switzerland (ICTRP)

ID di studio ICTRP
NCT06826105 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Effect of low dose pancrelipase with an oral nutritional supplement to improve nutrient bioavailability in patients at increased risk of malnutrition (BASEC)

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

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

Malattie studiate

Malnutrition

(ICTRP)

Intervento studiato

Drug: ZenpepDrug: Placebo

(ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio

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

(ICTRP)

Criteri di inclusione/esclusione

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)

non disponibile

Endpoint primari e secondari

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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
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)

ID secondari
2024-02519, ka24Schuetz (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06826105 (ICTRP)