Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
Not applicable · Testing LH VIOLA Supplementation · 4 sites · Lionhealth Srl Società Benefit
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing LH VIOLA Supplementation (a dietary supplement) to see if it can prevent disease or complications. Condition(s) listed: Ulcerative Colitis (Disorder), Crohn Disease and Malnutrition or Risk of Malnutrition.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Age 18-65 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis
- At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 146 participants are expected to take part.
- Start date: 2026-03-09.
- Main results expected around 2026-12-15 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in Italy.
Main thing being measured
- Proportion of participants with change in body weight from baseline at 16 weeks (Baseline - 16 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (Disorder); Crohn Disease; Malnutrition or Risk of Malnutrition; IBD |
| Lead sponsor | Lionhealth Srl Società Benefit |
| Enrollment | 146 (estimated) |
| Start date | 2026-03-09 |
| Primary completion (est.) | 2026-12-15 |
| First posted | 2026-02-25 |
| Last updated | 2026-06-25 |
| Official title | Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA |
| ClinicalTrials.gov ID | NCT07433946 |
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.
Full eligibility criteria (from the record)
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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Federico II | Naples | Italy | Recruiting |
| IRCCS Policlinico San Matteo - Pavia | Pavia | Italy | Recruiting |
| Ospedale Isola Tiberina - Gemelli Isola | Roma | Italy | Recruiting |
| IRCCS Humanitas | Rozzano, Milano | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.