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

NCT05429853 | Terminated

• 1 other identifier: 2021-A03216-35
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score

  60 days

• Evaluation of Tolerance at baseline,one and two months: for each Items

  60 days

• Evolution of quality of life

  60 days

• Evolution of anthropometric measures: handgrip test

  60 days

• Evolution of anthropometric measures: body weight evolution

  60 days

Study Arms (1)

Sondalis® HP 2 kcal (with or without fibre)

EXPERIMENTAL

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

Interventions

Sondalis® HP 2 kcal (with or without fibre) DIETARY_SUPPLEMENT

The participants will take the study product during the two months of the study.

Sondalis® HP 2 kcal (with or without fibre)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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 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),
• Non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Hôpital Claude Huriez

Lille, France

Location

Hôpital de l'Archet

Nice, France

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephane SCHNEIDER, Pr

  Hôpital de l'Archet

  PRINCIPAL INVESTIGATOR

• David SEGUY, Pr

  Hôpital Claude-Huriez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 23, 2022
• Study Start: July 8, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (2)