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

RecruitingNAAges 18 Years - 65 YearsAllLionhealth Srl Societร  Benefit
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In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ412 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 weigh

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • LH VIOLA Supplementation
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Where

4 sites
IRCCS Humanitas
Rozzano, Italy
AOU Federico II
Naples, Italy
IRCCS Policlinico San Matteo - Pavia
Pavia, Italy
Ospedale Isola Tiberina - Gemelli Isola
Roma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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