Partial enteral nutrition to help IBD patients at nutritional risk maintain weight
Official title: Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA
Run by Lionhealth Srl Società Benefit · NCT07433946 · Data updated 2026-11-12
We’re testing whether adding an oral nutritional supplement (LH VIOLA) to standard counseling helps adults with IBD who are at risk of malnutrition keep or gain weight over 16 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Lionhealth Srl Società Benefit Industry-sponsored |
| Locations | 4 sites (Rozzano, Milano and 3 other locations) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07433946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with Crohn’s disease or ulcerative colitis at risk of malnutrition per MUST.
✕Probably not a fit
Patients who do not experience weight or muscle changes or cannot tolerate the supplement may see limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label study randomizes 146 adults with Crohn’s disease or ulcerative colitis at risk of malnutrition to receive either nutritional counseling alone or counseling plus LH VIOLA partial enteral nutrition (≥412 kcal/day) for 16 weeks, with weight maintenance as the primary outcome. Secondary outcomes include weight at 24 weeks, handgrip strength, body composition, and metabolic parameters. MUST screening identifies eligible participants, and assessments include anthropometrics, bioelectrical impedance, and laboratory tests. The trial is conducted at four centers with Lionhealth as the sponsor.
Why it matters
Potential benefit: If successful, the approach could help patients with IBD maintain or improve body weight and muscle mass during treatment.
How similar studies have gone: Previous work suggests nutritional support can help malnourished IBD patients, but the impact of LH VIOLA specifically on weight and sarcopenia in this population is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Humanitas
Rozzano, Milano, Italy Recruiting -
AOU Federico II
Naples, Italy Recruiting -
IRCCS Policlinico San Matteo - Pavia
Pavia, Italy Recruiting -
Ospedale Isola Tiberina - Gemelli Isola
Roma, Italy Recruiting
Study contacts
- Principal investigator: Antonio Di Sabatino, MD - PhD — S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia
- Study coordinator: Roberta Majer, Pharmaceutical Chemistry and T
- Email: studiclinici@lionhealth.tech
- Phone: +39 3357664333
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.