Status:
TERMINATED
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN). The study aims to analyse the evolution of toleranc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05429853
Start Date
July 8 2022
End Date
May 28 2024
Last Update
December 19 2025
Active Locations (2)
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1
Hôpital Claude Huriez
Lille, France
2
Hôpital de l'Archet
Nice, France