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

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.

Study Overview

• Status: Terminated
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Sondalis® HP 2 kcal (with or without fibre)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hopital Claude Huriez
  • Nice, France
    • Hôpital de l'Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sondalis® HP 2 kcal (with or without fibre)	Dietary supplement: Sondalis® HP 2 kcal (with or without fibre); The participants will take the study product during the two months of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation tolerance from baseline after 2 months: Total Score	The digestive tolerance of enteral nutrition is assessed using a patient reported outcomes (PRO) questionnaire designed by clinicians. The questionnaire is composed of 9 items corresponding to the most frequent symptoms: gastro-oesophageal reflux, nausea, vomiting, feeling of an overfull stomach, bloating, flatulence, stomach pain, constipation, diarrhea. Each item includes questions relating to the frequency and impact of the symptom on daily life.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score	Same PRO than above	60 days
Evaluation of Tolerance at baseline,one and two months: for each Items	Same PRO than above	60 days
Evolution of quality of life	The quality of life is assessed with the NutriQoL® score described by Bischoff et al (Bischoff et al, 2020). The evolution of quality of life is evaluated between baseline, 1 month and 2 months after administration of the intervention. The NutriQoL® questionnaire is a specific tool to measure HRQoL in patients receiving HEN regardless of the underlying disease and the route of administration. It consists of 17 items grouped in two dimensions, which assess physical functioning, and activities of daily living and aspects of social life.	60 days
Evolution of anthropometric measures: handgrip test	The anthropometric measures are assessed with the handgrip test as recommended by SFNCM (Bossu-Estour et al, 2021). The evolution of anthropometric measures is evaluated between baseline, 1 month and 2 months after administration of the intervention. The Handgrip Test uses the Hand Grip Jamar® hydraulic hand dynamometers and the measurements are carried out according to the recommendations published by the "Comité Educationnel et de Pratique Clinique" of the SFNCM.	60 days
Evolution of anthropometric measures: body weight evolution	The anthropometric measures are assessed with the body weight evolution. The Weight is measured at the same time of day and under the same conditions (e.g. clothing).	60 days
Evolution of food intake	The food intake is assessed with the Food intake score (SEFI®). The evolution of food intake is evaluated between baseline, 1 month and 2 months after administration of the intervention. SEFI® allows a visual assessment of the patient's food intake, using a visual analogue scale, or a choice between consuming portions. The analogue scale is from 0: "I have eaten nothing" to 10: "I have eaten all".	30 days
Evolution of observance: score	The observance data are assessed with a score based on a questionnaire. The questionnaire assesses the frequency of difficulties in consuming the entire enteral nutrition prescription. The evolution of observance is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Evolution of observance: number of bags	The observance data are assessed with the number of bags unused for 1 month. The evolution of observance is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Volume	The EN prescription procedure is assessed with the volume per 1 month administered. The evolution of EN prescription is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Time	The EN prescription procedure is assessed with the administration time per 1 month administered. The evolution of EN prescription is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Number of Bags	The EN prescription procedure is assessed with the number of bags per 1 month administered. The evolution of EN prescription is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Supplementary Hydration	The EN prescription procedure is assessed with the supplementary hydration per 1 month administered. The evolution of EN prescription is evaluated between baseline, 1 month and 2 months after administration of the intervention.	30 days
Safety events reporting	The safety is assessed with the report of safety events during the entire study period. Study adverse events are classified by system organ class (SOC), preferred terms (PT) in accordance with the current version of the Medical dictionary for Regulatory Activities (MedDRA), causality and seriousness.	60 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Stephane SCHNEIDER, Pr, Hôpital de l'Archet; Principal Investigator: David SEGUY, Pr, Hôpital Claude-Huriez

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Dietary Fiber
• Other Study ID Numbers: 2021-A03216-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No