TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal (SONDALIS)
Primary Purpose
Malnutrition
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sondalis® HP 2 kcal (with or without fibre)
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition
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
Sites / Locations
- Hôpital Claude HuriezRecruiting
- Hôpital de l'Archet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sondalis® HP 2 kcal (with or without fibre)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score
Same PRO than above
Evaluation of Tolerance at baseline,one and two months: for each Items
Same PRO than above
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.
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.
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).
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".
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05429853
First Posted
June 2, 2022
Last Updated
September 12, 2022
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT05429853
Brief Title
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
Acronym
SONDALIS
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
June 13, 2023 (Anticipated)
Study Completion Date
August 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sondalis® HP 2 kcal (with or without fibre)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Sondalis® HP 2 kcal (with or without fibre)
Intervention Description
The participants will take the study product during the two months of the study.
Primary Outcome Measure Information:
Title
Evaluation tolerance from baseline after 2 months: Total Score
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score
Description
Same PRO than above
Time Frame
60 days
Title
Evaluation of Tolerance at baseline,one and two months: for each Items
Description
Same PRO than above
Time Frame
60 days
Title
Evolution of quality of life
Description
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.
Time Frame
60 days
Title
Evolution of anthropometric measures: handgrip test
Description
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.
Time Frame
60 days
Title
Evolution of anthropometric measures: body weight evolution
Description
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).
Time Frame
60 days
Title
Evolution of food intake
Description
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".
Time Frame
30 days
Title
Evolution of observance: score
Description
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.
Time Frame
30 days
Title
Evolution of observance: number of bags
Description
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.
Time Frame
30 days
Title
Evolution of Enteral Nutrition (EN) prescription procedure: Volume
Description
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.
Time Frame
30 days
Title
Evolution of Enteral Nutrition (EN) prescription procedure: Time
Description
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.
Time Frame
30 days
Title
Evolution of Enteral Nutrition (EN) prescription procedure: Number of Bags
Description
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.
Time Frame
30 days
Title
Evolution of Enteral Nutrition (EN) prescription procedure: Supplementary Hydration
Description
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.
Time Frame
30 days
Title
Safety events reporting
Description
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.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine DIVE-POULETTY, Dr
Phone
+33(0)1 87 60 39 50
Email
Catherine.DivePouletty@fr.nestle.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie PAPIN
Phone
+33 (0)6 75 24 25 09
Email
Sylvie.Papin@fr.nestle.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane SCHNEIDER, Pr
Organizational Affiliation
Hôpital de l'Archet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David SEGUY, Pr
Organizational Affiliation
Hôpital Claude-Huriez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David SEGUY, Pr
Facility Name
Hôpital de l'Archet
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane SCHNEIDER, Pr
First Name & Middle Initial & Last Name & Degree
Mohamed ARAB, Dr
12. IPD Sharing Statement
Learn more about this trial
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
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