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

NCT ID: NCT05429853

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2024-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sondalis® HP 2 kcal (with or without fibre)

Group Type EXPERIMENTAL

Sondalis® HP 2 kcal (with or without fibre)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Sondalis® HP 2 kcal (with or without fibre)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephane SCHNEIDER, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital de l'Archet

David SEGUY, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Claude-Huriez

Locations

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Hôpital Claude Huriez

Lille, , France

Site Status

Hôpital de l'Archet

Nice, , France

Site Status

Countries

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France

Other Identifiers

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2021-A03216-35

Identifier Type: -

Identifier Source: org_study_id