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Taking people in ItalyNo phase

Nutrition Drink to Prevent Weight and Muscle Loss in Inflammatory Bowel Disease

Tests LH VIOLA supplement plus counseling in adults with inflammatory bowel disease at malnutrition risk.

Plain-language title generated from the registry record
Registry title: Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA

Key facts

Where
Naples, Pavia, Roma, and Rozzano, ItalySee the 4 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease or ulcerative colitis who are at risk of malnutrition. It tests a nutrition drink (LH VIOLA) added to nutritional counseling.

Age
18-65 years
Sex
Women and men can join.
Disease stage
Crohn's disease or ulcerative colitis, at risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST).

Main reasons for not taking part

  • Following an exclusion diet (CDED)
  • Currently in hospital
  • Pregnancy
  • Needing a low-protein diet

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07433946, who can take part

Where in Italy

  • AOU Federico IINaples, ItalyTaking people
  • IRCCS Policlinico San Matteo, PaviaPavia, ItalyTaking people
  • Ospedale Isola Tiberina - Gemelli IsolaRoma, ItalyTaking people
  • IRCCS HumanitasRozzano, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Lionhealth Srl Società Benefit
Trial code
NCT07433946
Record updated
25 June 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Following an exclusion diet (CDED); Current hospitalization; Pregnancy; Requirement for a low-protein diet.

ClinicalTrials.gov NCT07433946