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

Sponsor
Lionhealth Srl Società Benefit
Study ID
NCT07433946
Status
Recruiting
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Conditions

  • Crohn Disease
  • IBD
  • Malnutrition or Risk of Malnutrition
  • Ulcerative Colitis (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LH VIOLA Supplementation — DIETARY_SUPPLEMENT
    Oral administration of LH VIOLA, a specialized medical food (≥412 kcal/day), for 16 weeks, together with nutritional counseling provided by a clinical dietitian. Participants monitored for adherence, tolerability, weight, body composition, and muscle strength.

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
May 2026
Primary completion
Dec 15, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental Arm
    Nutritional counseling + LH VIOLA oral supplementation. Patients receive ≥412 kcal/day of LH VIOLA for 16 weeks, in addition to standard nutritional counseling delivered by a clinical dietitian.
  • No Intervention: Control Arm
    Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.

Primary Outcome Measure

Proportion of participants with change in body weight from baseline at 16 weeks [ Time Frame: Baseline - 16 weeks ]

Central Contacts

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