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

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

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 tolerance and quality of life of HEN patients after switching from a High Protein High Energy (HPHE) polymeric Enteral Nutrition (EN) formula with or without fibre to Sondalis® HP 2kcal, with or without fibre. Eligible patients will give their written consent to participate before being included into the study.

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