MalnutritionSONDALISNCT05429853
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
A study testing Sondalis® HP 2 kcal (with or without fibre) in people with Malnutrition, run by Société des Produits Nestlé (SPN) at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Sondalis® HP 2 kcal (with or without fibre)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jul 2022to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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,
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Sondalis® HP 2 kcal (with or without fibre)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sondalis® HP 2 kcal (with or without fibre)Dietary supplement
The participants will take the study product during the two months of the study.
| Study group | Role | What they receive |
|---|---|---|
| Sondalis® HP 2 kcal (with or without fibre) | Experimental | Not described Receives: Dietary Supplement: Sondalis® HP 2 kcal (with or without fibre) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (13)
Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score
Same PRO than above
Measured: 60 days
Evaluation of Tolerance at baseline,one and two months: for each Items
Same PRO than above
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start8 Jul 2022
- Primary completion28 May 2024
- Study completion28 May 2024
Why it stopped: The study has been stopped prematurely for lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephane SCHNEIDER, Pr, Principal investigator, Hôpital de l'ArchetDavid SEGUY, Pr, Principal investigator, Hôpital Claude-Huriez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429853
- Sponsor's protocol ID
- 2021-A03216-35
- Acronym
- SONDALIS
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2022
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
- ClinicalTrials.gov ID
- NCT05429853
- Acronym / sponsor ID
- SONDALIS / 2021-A03216-35
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been stopped prematurely for lack of inclusions
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sondalis® HP 2 kcal (with or without fibre) | Experimental | Dietary Supplement: Sondalis® HP 2 kcal (with or without fibre) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sondalis® HP 2 kcal (with or without fibre)The participants will take the study product during the two months of the study. | Dietary supplement | Sondalis® HP 2 kcal (with or without fibre) |
Primary outcome
Evaluation tolerance from baseline after 2 months: Total Score
Time frame: 60 days
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.
13 secondary outcomes
Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score
Time frame: 60 days
Evaluation of Tolerance at baseline,one and two months: for each Items
Time frame: 60 days
Evolution of quality of life
Time frame: 60 days
Evolution of anthropometric measures: handgrip test
Time frame: 60 days
Evolution of anthropometric measures: body weight evolution
Time frame: 60 days
Evolution of food intake
Time frame: 30 days
Evolution of observance: score
Time frame: 30 days
Evolution of observance: number of bags
Time frame: 30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Volume
Time frame: 30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Time
Time frame: 30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Number of Bags
Time frame: 30 days
Evolution of Enteral Nutrition (EN) prescription procedure: Supplementary Hydration
Time frame: 30 days
Safety events reporting
Time frame: 60 days
Results and safety
The study was stopped early (reason given: The study has been stopped prematurely for lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane SCHNEIDER, Pr principal investigator
Hôpital de l'Archet
David SEGUY, Pr principal investigator
Hôpital Claude-Huriez
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sondalis® HP 2 kcal (with or without fibre) in people with Malnutrition, run by Société des Produits Nestlé (SPN) at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has been stopped prematurely for lack of inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation tolerance from baseline after 2 months: Total Score (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.