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

Summary

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

LH VIOLA Supplementation

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.

Sponsors & Collaborators

• Lionhealth Srl Società Benefit

  lead INDUSTRY

Principal Investigators

• Antonio Di Sabatino, MD - PhD · S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia

• Daniela Pugliese, MD - PhD · Emergenza e Medicina Interna - Ospedale Isola Tiberina-Gemelli Isola

• Alessandro Armuzzi, MD - PhD · IBD Center at IRCCS Humatitas Research Hospital - Department of Biomedical Sciences

• Fabiana Castiglione, MD - PhD · Department of Clinical Medicine and Surgery at AOU Federico II

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-09

Primary Completion

2026-12-15

Completion

2027-01-31

Countries

• Italy

Study Locations