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New tube feeding formula aims to ease digestive troubles

NCT ID NCT05429853

Symptom relief Sponsor: Société des Produits Nestlé (SPN) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether switching to a high-energy, high-protein tube feeding formula (Sondalis HP 2 kcal) improves digestive comfort and quality of life in adults who have trouble tolerating their current home tube feeding. Seventeen adults on home enteral nutrition took the formula for two months. The main goal was to see if digestive symptoms like bloating, nausea, and stomach pain got better.

What this could mean

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

Active substance
Sondalis HP 2 kcal (a high-energy, high-protein dietary supplement with or without fiber)
What this could lead to
If successful, this could show that switching to this formula helps reduce digestive discomfort and improves quality of life for people on home tube feeding.
What could go wrong
This was a small, early study (17 participants) that was terminated, so results may be incomplete. The findings may not apply to all patients on enteral nutrition.

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

17 people

The number who actually took part.

Started

Jul 2022

Finished

May 2024

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 years and older

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: * Men or women aged ≥18 years, * Being under EN with polymeric HPHE product with or without fibre (=HPHE), * Stable caloric prescription during HEN for at least one month, * Patient with at least a score of 2 on at least 1 item of tolerance questionnaire, * Investigators' judgement to change to HPHE concentrated, * HEN is planned for ≥ 8 weeks, * Life expectancy ≥ 3 months. * Patient or his/her primary caregiver was required to be able to understand the study and to be fully free to participate in it, * Patient having signed an informed consent, * Patient registered with a social security scheme, * Patient willing to adhere to study procedures, Exclusion Criteria: * Pregnancy or breastfeeding, * Being either under PN or ONS, * Acute intestinal disease such as gastric ulcer, gastritis, gastroparesis, * Patient under prokinetic agents during the study phase, * Patient receiving antibiotic, chemotherapy in the 7 days prior to inclusion, * Patient receiving radiation treatment except head and neck location, * Patient expected to receive chemotherapy or radiation treatment during the study except head and neck location , * Severe infectious disease and/or fever \> 38,5°C, * Emergent hospitalization within last month, * Known allergy or intolerance to any of the Sondalis® HP 2kcal with or without fibre ingredients, * Previous treatment with HPHE concentrated at home (2kcal), * Current participation in another intervention study or participation in a previous study for which exclusion period applies. * Non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian

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Conditions

The condition(s) this trial relates to.

Malnutrition nutritional deficiency disease

As listed by the trial registrant

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

Malnutrition

Contacts and locations

Locations

  • Hôpital Claude Huriez

    Lille, France

  • Hôpital de l'Archet

    Nice, France

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