Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060172) titled 'The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms' on Jan. 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Mejiro Daini Hospital, Etsudenkai Medical Corporation

Condition: Condition - Patients receiving enteral nutrition due to difficulty with oral intake or poor nutritional status. Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To evaluate the efficacy of NVIF2025-2 in alleviating diarrhea symptoms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Base Enteral nutrition formula (1 week ingestion) -> Base Enteral nutrition formula containing NVIF-02. (4 weeks ingestion)

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - Hospitalized patients receiving enteral nutrition due to poor oral intake or malnutrition Key exclusion criteria - Patients with complications, e.g., pancreatic fistula (post-pancreaticoduodenectomy) Patients scheduled to receive total parenteral nutrition (TPN) Patients with clinically significant infections Patients with respiratory failure Patients receiving antimicrobial agents Patients with an estimated glomerular filtration rate (eGFR) of stage 4 or lower Patients with severe hepatic dysfunction (e.g., marked jaundice, ascites, or edema) Patients with uncontrolled diabetes mellitus Patients with known allergies to components of the investigational food Patients with a history of hypersensitivity to components of the investigational food Other patients deemed unsuitable by the principal investigator Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 15 Day Anticipated trial start date - 2025 Year 12 Month 15 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068735

Disclaimer: Curated by HT Syndication.