Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA

What this Trial Is About

Researchers are evaluating the effects of partial enteral nutrition using LH VIOLA in patients with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis, who are at risk of malnutrition. This open-label, randomized study aims to assess whether LH VIOLA can help maintain or restore body weight and muscle strength, improve body composition and metabolic parameters, and enhance quality of life in these patients. The study addresses the common issues of malabsorption, weight loss, sarcopenia, and malnutrition that impact treatment outcomes and hospitalization risk in IBD. Participants will be randomly assigned to one of two groups: one receiving nutritional counseling plus oral LH VIOLA supplementation providing at least 412 kcal/day for 16 weeks, and the other receiving nutritional counseling alone. The intervention lasts 16 weeks, followed by an 8-week observation period without supplementation. Nutritional counseling is delivered by a clinical dietitian in both groups. The study will enroll 146 patients across four centers. During the study, participants will attend several visits including baseline, mid-intervention, end of intervention, and follow-up at 24 weeks. Assessments include body weight, body composition via bioelectrical impedance analysis, handgrip strength, laboratory tests for vitamin B12, vitamin D, and pre-albumin, and quality of life questionnaires. Researchers will monitor adherence to LH VIOLA, gastrointestinal tolerability, and changes in malnutrition risk using the Malnutrition Universal Screening Tool (MUST). The main outcome is the proportion of patients maintaining or gaining weight at 16 weeks.

Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA