Clinical trial NCT05429853: TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
Official title: TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.


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

Primary outcomes:
measure: Evaluation tolerance from baseline after 2 months: Total Score
timeFrame: 60 days
Secondary outcomes:
measure: Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score
timeFrame: 60 days
measure: Evaluation of Tolerance at baseline,one and two months: for each Items
timeFrame: 60 days
measure: Evolution of quality of life
timeFrame: 60 days
measure: Evolution of anthropometric measures: handgrip test
timeFrame: 60 days
measure: Evolution of anthropometric measures: body weight evolution
timeFrame: 60 days
measure: Evolution of food intake
timeFrame: 30 days
measure: Evolution of observance: score
timeFrame: 30 days
measure: Evolution of observance: number of bags
timeFrame: 30 days
measure: Evolution of Enteral Nutrition (EN) prescription procedure: Volume
timeFrame: 30 days
measure: Evolution of Enteral Nutrition (EN) prescription procedure: Time
timeFrame: 30 days
measure: Evolution of Enteral Nutrition (EN) prescription procedure: Number of Bags
timeFrame: 30 days
measure: Evolution of Enteral Nutrition (EN) prescription procedure: Supplementary Hydration
timeFrame: 30 days
measure: Safety events reporting
timeFrame: 60 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Nice
country: France
facility: Hôpital de l'Archet
Study officials:
affiliation: Hôpital de l'Archet
name: Stephane SCHNEIDER, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Claude-Huriez
name: David SEGUY, Pr
role: PRINCIPAL_INVESTIGATOR
References: