Investigating a new high protein formula for patients on home enteral nutrition

TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal

This study is testing a new high-protein formula to see if it helps adults on home enteral nutrition feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 109 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Lille and 1 other locations)
• Trial ID: NCT05429853 on ClinicalTrials.gov

What this trial studies

This multicentre, prospective, open-label study aims to evaluate the tolerance and quality of life in adult patients undergoing home enteral nutrition (HEN) who are currently using a high protein high energy (HPHE) formula. Participants will switch to the Sondalis® HP 2 kcal formula, with or without fiber, for a duration of two months. The study will assess the evolution of tolerance through a questionnaire and monitor the overall quality of life of the patients. Written consent will be obtained from all eligible participants before inclusion in the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are currently using a polymeric HPHE product for home enteral nutrition.

Not a fit: Patients who are pregnant, breastfeeding, or have acute intestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the tolerance and quality of life for patients relying on home enteral nutrition.

How similar studies have performed: While this approach is novel, similar studies have shown promise in improving nutritional tolerance in enteral nutrition patients.

Eligibility criteria

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

Where this trial is running

Lille and 1 other locations

• Hôpital Claude Huriez — Lille, France (Recruiting)
• Hôpital de l'Archet — Nice, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Stephane SCHNEIDER, Pr — Hôpital de l'Archet
• Study coordinator: Catherine DIVE-POULETTY, Dr

Conditions Malnutrition