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

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT06826105 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Effect of low dose pancrelipase with an oral nutritional supplement to improve nutrient bioavailability in patients at increased risk of malnutrition (BASEC)

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

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

Maladie en cours d'investigation

Malnutrition

(ICTRP)

Intervention étudiée

Drug: ZenpepDrug: Placebo

(ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude

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

(ICTRP)

Critères d'inclusion/exclusion

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 disponible

Critères d'évaluation principaux et secondaires

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)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
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 secondaires
2024-02519, ka24Schuetz (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06826105 (ICTRP)