NCT07433946 Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
| NCT ID | NCT07433946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lionhealth Srl Società Benefit |
| Condition | Ulcerative Colitis (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2026-03-09 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Antonio Di Sabatino, MD - PhD
PRINCIPAL INVESTIGATOR
S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia
Frequently Asked Questions
Who can join the NCT07433946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ulcerative Colitis (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433946 currently recruiting?
Yes, NCT07433946 is actively recruiting participants. Contact the research team at studiclinici@lionhealth.tech for enrollment information.
Where is the NCT07433946 trial being conducted?
This trial is being conducted at Rozzano, Italy, Naples, Italy, Pavia, Italy, Roma, Italy.
Who is sponsoring the NCT07433946 clinical trial?
NCT07433946 is sponsored by Lionhealth Srl Società Benefit. The principal investigator is Antonio Di Sabatino, MD - PhD at S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia. The trial plans to enroll 146 participants.
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