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

Nestlé

Status

Terminated

Conditions

Malnutrition

Treatments

Dietary Supplement: Sondalis® HP 2 kcal (with or without fibre)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05429853

2021-A03216-35

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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