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Can a medical food fight malnutrition in IBD?

NCT ID NCT07433946

Disease control Sponsor: Lionhealth Srl Società Benefit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special medical food called LH VIOLA, taken as a partial replacement for regular meals, can help people with Crohn's disease or ulcerative colitis who are at risk of malnutrition maintain or regain weight and muscle strength. About 146 participants will either receive nutritional counseling alone or counseling plus the supplement for 16 weeks. The main goal is to see if more people in the supplement group can keep or gain weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LH VIOLA (a specialized medical food supplement)
What this could lead to
If it works, this could provide a simple nutritional supplement to help IBD patients avoid dangerous weight loss and muscle wasting.
What could go wrong
This is a small, early-stage nutritional study, not a drug trial. The supplement may not significantly improve weight or muscle strength, and some patients may have trouble tolerating it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease Malnutrition nutritional deficiency disease Sarcopenia ulcerative colitis Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease IBD Malnutrition or risk of malnutrition Ulcerative colitis (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Federico II

    RECRUITING

    Naples, Italy

  • IRCCS Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • IRCCS Policlinico San Matteo - Pavia

    RECRUITING

    Pavia, 27100, Italy

  • Ospedale Isola Tiberina - Gemelli Isola

    RECRUITING

    Roma, 00186, Italy

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