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

Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; IBD; Ulcerative Colitis (Disorder); Malnutrition or Risk of Malnutrition
• Intervention / Treatment: Dietary supplement: LH VIOLA Supplementation

Detailed Description

Background:

Inflammatory Bowel Disease (IBD), including Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic immune-mediated condition characterized by relapsing and remitting courses. Patients with IBD, particularly those with Crohn's Disease, are at risk of malabsorption of vitamins (B12, D), minerals (calcium, iron), anemia, and sarcopenia, leading to malnutrition. Malnutrition negatively affects quality of life, response to therapy, and increases the risk of hospitalization and surgical interventions. ESPEN guidelines recommend regular nutritional assessment and targeted interventions for patients at risk of malnutrition.

The Malnutrition Universal Screening Tool (MUST) will be used to identify patients at nutritional risk. Other nutritional assessments include anthropometric measures, body composition analysis (BIA/BIVA), handgrip strength evaluation, and laboratory tests (vitamins B12/D, pre-albumin). Despite these recommendations, the effect of partial enteral nutrition using a specialized medical food (LH VIOLA) on body weight, muscle mass, and disease activity in patients with IBD at nutritional risk has not been fully investigated.

Study Objectives:

Primary Objective: Evaluate the maintenance or recovery of body weight after 16 weeks of LH VIOLA supplementation, measured in kilograms.

Secondary Objectives: Evaluate weight maintenance or improvement at 24 weeks; assess muscle mass recovery or maintenance (handgrip strength); assess body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin); evaluate quality of life (SF-12 questionnaire); assess economic impact; evaluate adherence to nutritional intervention (≥50% intake); assess gastrointestinal tolerability; evaluate reduction in malnutrition risk (MUST score).

Study Design:

This is a multicenter, open-label, randomized, two-arm interventional nutritional study. A total of 146 patients (73 per arm, including a 15% anticipated dropout) will be enrolled across 4 centers. Patients will be randomized 1:1 to either:

Nutritional counseling alone (control arm)

Nutritional counseling plus oral LH VIOLA supplementation (≥412 kcal/day for 16 weeks) (intervention arm)

Procedures and Follow-up:

Patients will undergo an initial screening, a baseline visit (T0), a telephone follow-up (T1) at the start of product intake, a second hospital visit (T2), a second telephone follow-up (T3), a third hospital visit (T4) at week 16 to complete product intake, and a final follow-up visit (T5) at week 24. During visits, patients will undergo assessments of body weight, body composition, muscle strength, biochemical parameters, and quality of life questionnaires. Adherence and tolerability to LH VIOLA will be monitored.

Study Duration:

Each participant will be involved for 24 weeks (16 weeks of intervention plus 8 weeks of follow-up). The total study duration is 18 months, including 12 months for patient recruitment and 6 months for follow-up.

Statistical Plan and Sample Size:

The sample size is calculated based on the primary endpoint: proportion of patients maintaining or gaining weight at 16 weeks. The study aims to detect an increase from 40% (control) to 65% (intervention), with an alpha of 5% and 80% power, considering a 1:1 randomization. Accounting for a 15% dropout rate, 146 patients will be enrolled (73 per arm).

Significance:

This study will provide critical evidence on the efficacy of partial enteral nutrition using LH VIOLA in preventing weight loss, preserving muscle mass, and improving metabolic and quality of life outcomes in patients with IBD at risk of malnutrition. It will support evidence-based nutritional interventions and inform clinical guidelines for nutritional management in IBD.

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Majer, Pharmaceutical Chemistry and T; Phone Number: +39 3357664333; Email: studiclinici@lionhealth.tech
• Study Contact Backup: Name: Lucio Vitiello, Biological Sciences; Phone Number: +39 3331756863; Email: vitiello@lionhealth.tech

Study Locations

• Italy
  • Naples, Italy
    • Recruiting
    • AOU Federico II
    • Contact: Fabiana Castiglione, MD - PhD; Phone Number: +39 3472801673; Email: fabcasti@unina.it
  • Pavia, Italy, 27100
    • Not yet recruiting
    • IRCCS Policlinico San Matteo - Pavia
    • Contact: Antonio Di Sabatino, MD - PhD; Phone Number: +39 0382502973; Email: a.disabatino@smatteo.pv.it
  • Roma, Italy, 00186
    • Recruiting
    • Ospedale Isola Tiberina - Gemelli Isola
    • Contact: Daniela Pugliese, MD - PhD; Phone Number: +39 0630154678; Email: daniela.pugliese@fbf-isola.it
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Not yet recruiting
      • IRCCS Humanitas
      • Contact: Alessandro Armuzzi, MD - PhD; Phone Number: +39 3387367765; Email: alessandro.armuzzi@hunimed.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 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; 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.
No Intervention: Control Arm; Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight at 24 weeks	Body weight will be measured in kilograms at baseline (T0) and at 24 weeks. Change in body weight is defined as the difference between the 24-week and baseline measurements. Positive values indicate an increase in body weight, and negative values indicate a decrease.	Baseline - 24 weeks
Change in handgrip strength from baseline to follow-up	Handgrip strength will be measured in kilograms using a dynamometer at baseline and follow-up visits. Change in handgrip strength is defined as the difference between follow-up and baseline measurements. Higher values indicate greater muscle strength.	Baseline - 16 and 24 weeks
Body composition (BIA)	Body composition will be assessed using bioelectrical impedance analysis (BIA) at baseline and follow-up visits. Parameters include fat mass and fat-free mass, expressed in kilograms and percentage.	Baseline - 16 and 24 weeks
Change in total direct and indirect healthcare costs from baseline	Total direct and indirect healthcare costs associated with IBD management will be collected for each participant in both study arms. Costs will include hospitalizations, outpatient visits, medications, and indirect costs (e.g., lost work days), expressed in local currency (e.g., USD or EUR) over the 24-week study period	24 weeks
Change in Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12)	The Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12), range 0-100; higher scores indicate better physical health status. The PCS score will be assessed at baseline, 16 weeks, and 24 weeks.	24 weeks
Change in Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12)	The Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12), range 0-100; higher scores indicate better mental health status. The MCS score will be assessed at baseline, 16 weeks, and 24 weeks.	24 weeks
Proportion of participants with ≥50% intake of prescribed LH VIOLA supplement	Adherence to the prescribed LH VIOLA supplement will be assessed at each follow-up visit. The outcome is defined as the proportion of participants consuming at least 50% of the prescribed daily dose over the study period (baseline to 24 weeks)	16 weeks
Incidence and severity of gastrointestinal symptoms related to LH VIOLA intake	Gastrointestinal (GI) symptoms including nausea, diarrhea, bloating, and abdominal pain will be recorded at each study visit and follow-up. Severity will be graded on a standardized 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Time Frame: baseline to 24 weeks	16 weeks
Change in malnutrition risk measured by the Malnutrition Universal Screening Tool (MUST)	Malnutrition risk will be assessed using the Malnutrition Universal Screening Tool (MUST; score range 0-6) at baseline, 16 weeks, and 24 weeks. MUST is a validated screening tool used to identify risk of malnutrition. Scores range from 0 to 6, where higher scores indicate a greater risk of malnutrition	Baseline - 16 and 24 weeks
Change in serum vitamin B12 levels from baselin	Serum vitamin B12 levels will be measured at baseline and follow-up visits. Concentrations will be expressed in pg/mL.	Baseline - 16 - 24 Weeks
Change in serum vitamin D levels from baseline	Serum 25-hydroxyvitamin D levels will be measured at baseline and follow-up visits and expressed in ng/mL.	Baseline - 16 - 24 weeks
Change in serum prealbumin levels from baseline	Serum prealbumin levels will be measured at baseline and follow-up visits and expressed in mg/dL.	Baseline - 16 - 24 weeks

Collaborators and Investigators

• Sponsor: Lionhealth Srl Società Benefit
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: weight loss; Sarcopenia; IBD; Malnutrition; enteral nutrition; clinical nutrition; ONS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Body Weight; Intestinal Diseases; Body Weight Changes; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Muscular Atrophy; Atrophy; Colitis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Weight Loss; Colitis, Ulcerative; Crohn Disease; Sarcopenia
• Other Study ID Numbers: LH-1 SIMBA (Other Identifier: LionHealth Srl Società Benefit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared, including demographics, baseline characteristics, primary and secondary outcomes, laboratory values, body composition measures, adherence, and tolerability data. Additional documents available include the study protocol, statistical analysis plan, and informed consent form.
• IPD Sharing 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)
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No