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

NCT07433946 | Recruiting DMC

• 1 other identifier: LH-1 SIMBA
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 4

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.

Conditions

Ulcerative Colitis (Disorder); Crohn Disease; Malnutrition or Risk of Malnutrition; IBD

Keywords

IBD; Malnutrition; Sarcopenia; ONS; enteral nutrition; weight loss; clinical nutrition

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with change in body weight from baseline at 16 weeks

  Body weight will be measured in kilograms at baseline (T0) and at 16 weeks. The outcome is defined as the proportion of participants with a change in body weight greater than or equal to +1 kg from baseline.

  Baseline - 16 weeks

Secondary Outcomes (12)

• Change in body weight at 24 weeks

  Baseline - 24 weeks

• Change in handgrip strength from baseline to follow-up

  Baseline - 16 and 24 weeks

• Body composition (BIA)

  Baseline - 16 and 24 weeks

• Change in total direct and indirect healthcare costs from baseline

  24 weeks

• Change in Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12)

  24 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Nutritional counseling + LH VIOLA oral supplementation. Patients receive ≥412 kcal/day of LH VIOLA for 16 weeks, in addition to standard nutritional counseling delivered by a clinical dietitian.

Dietary Supplement: LH VIOLA Supplementation

Control Arm

NO INTERVENTION

Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current hospitalization
• Pregnancy
• Requirement for a low-protein diet

Sponsors & Collaborators

• Lionhealth Srl Società Benefit: lead

Study Sites (4)

IRCCS Humanitas

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

AOU Federico II

Naples, Italy

RECRUITING

IRCCS Policlinico San Matteo - Pavia

Pavia, 27100, Italy

NOT YET RECRUITING

Ospedale Isola Tiberina - Gemelli Isola

Roma, 00186, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Malnutrition; Sarcopenia; Weight Loss

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight Changes; Body Weight

Study Officials

• Antonio Di Sabatino, MD - PhD

  S.C. General Medicine Fondazione IRCCS Policlinico San Matteo - Pavia

  PRINCIPAL INVESTIGATOR

• Daniela Pugliese, MD - PhD

  Emergenza e Medicina Interna - Ospedale Isola Tiberina-Gemelli Isola

  PRINCIPAL INVESTIGATOR

• Alessandro Armuzzi, MD - PhD

  IBD Center at IRCCS Humatitas Research Hospital - Department of Biomedical Sciences

  PRINCIPAL INVESTIGATOR

• Fabiana Castiglione, MD - PhD

  Department of Clinical Medicine and Surgery at AOU Federico II

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Majer, Pharmaceutical Chemistry and T

CONTACT

+39 3357664333; studiclinici@lionhealth.tech

Lucio Vitiello, Biological Sciences

CONTACT

+39 3331756863; vitiello@lionhealth.tech

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to one of two parallel arms. In the experimental arm, participants receive oral LH VIOLA supplementation (≥412 kcal/day) plus nutritional counseling for 16 weeks. In the control arm, participants receive nutritional counseling alone. All participants are followed for a total of 24 weeks (16 weeks intervention + 8 weeks follow-up). The study is open-label, so both participants and investigators are aware of treatment assignment.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: 12 months after study completion (i.e., 1 February 2028, estimated) End date: 5 years after start date (i.e., 1 February 2033)
• Access Criteria: Qualified researchers from academia or industry may request access to de-identified individual participant data, including demographics, baseline characteristics, primary and secondary outcomes, laboratory values, body composition, muscle strength, adherence, and tolerability data. Access requires submission of a research proposal and signing a Data Use Agreement to ensure confidentiality and proper use of the data.

Locations

IT (4)