An interventional study of LH VIOLA Supplementation in Ulcerative Colitis (Disorder), Crohn Disease and Malnutrition or Risk of Malnutrition, sponsored by Lionhealth Srl Società Benefit. Recruiting at 4 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Lionhealth Srl Società Benefit · Not applicable, Interventional, and Prevention
Among 209 studies in Colitis, Ulcerative with a site in Italy — 48 open to participants now, 77 under way, 27 of them phase 3. Colitis, Ulcerative · Italy.
Among the 209 studies in Colitis, Ulcerative with a site in Italy, this one is the 103rd largest by planned enrollment of the 175 interventional ones that give a count, is one of 17 that started in 2026, is one of 24 with no phase, reaches primary completion later than 30 of the 76 other live ones, and was the 191st registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
Browse Colitis, Ulcerative studies →48 of the 209 studies in Colitis, Ulcerative with a site in Italy are open now. Recruiting first, the newest first:
Palisade Bio · Sites in Italy, United States, Canada and 9 more countries
Pfizer · Sites in Italy, United States, Australia and 7 more countries
Janssen Research & Development, LLC · Sites in Italy, United States, Argentina and 30 more countries
Eli Lilly and Company · Sites in Italy, United States, Belgium and 7 more countries
University of Padova · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 77 · Phase 3 73 · Phase 4 9
First in 2003; this study’s year is marked. 17 started in 2026.
This study's planned enrollment of 146 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 182 across the 175 interventional studies, 279 across the 34 observational. Of the 122 that completed or were terminated, 74 (61%) have results posted.
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153 of 209 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Lionhealth Srl Società Benefit as lead sponsor.
Lionhealth Srl Società Benefit has 1 study filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
23 of the studies in Colitis, Ulcerative with a site in Italy that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
Among the 209 studies in Colitis, Ulcerative with a site in Italy, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.
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.
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.
Time frame: Baseline - 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline - 16 - 24 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Data sharing details ↗ · www.lionhealth.tech
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 236 interventional studies with no phase under Colitis, Ulcerative, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 9 months is below that.
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