Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
Recruiting · NCT07433946 · Interventional (participants receive a specific treatment) · Lead sponsor: Lionhealth Srl Società Benefit
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers. IBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk. Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score). The study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.
Who can take part
Inclusion criteria
- Age 18-65 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis
- At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)
- Ability to provide informed consent
- Women of childbearing potential must use effective contraception
Exclusion criteria
- Following an exclusion diet (CDED)
- Current hospitalization
- Pregnancy
- Requirement for a low-protein diet
Where it is running
8 locations listed.
- AOU Federico II - Naples, Italy
- AOU Federico II - Naples, Italy
- IRCCS Policlinico San Matteo - Pavia - Pavia, Italy
- IRCCS Policlinico San Matteo - Pavia - Pavia, Italy
- Ospedale Isola Tiberina - Gemelli Isola - Roma, Italy
- Ospedale Isola Tiberina - Gemelli Isola - Roma, Italy
- IRCCS Humanitas - Rozzano, Milano, Italy
- IRCCS Humanitas - Rozzano, Milano, Italy