MalabsorptionPEPSNCT02590120
Enteral Nutrition and Amino Acid Absorption
A study testing Enteral nutrition in people with Malabsorption, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
The purpose of this study is to evaluate amino acid absorption with two different type of proteins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malabsorption
- What is being tested?
- Enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2021
- 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
- Patient with gastrointestinal disorder : citrulline plasma concentration < 20 µmol/L and/or xylose plasma concentration < 1,7 mmol/L
- Patient under enteral nutrition at home
- Patient already receiving 1 L by day
Who cannot join
- Obese patient BMI > 30
- Diabetes
- Renal or liver failure
- Glucocorticoids treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique
The purpose of this study is to evaluate amino acid absorption with two different type of proteins.
- Conditions
- Malabsorption
- Being tested
- Enteral nutrition
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutritionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition product : product A | Active comparator | Administration during 16 hours. Receives: Dietary Supplement: Enteral nutrition |
| Enteral nutrition product : product B | Active comparator | Administration during 16 hours. Receives: Dietary Supplement: Enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid absorption profile
Area under the curve of amino acid plasma concentration
Measured: 48 hours
Secondary outcomes (5)
Tolerance
Description and occurence of adverse events
Measured: 48 hours
Nutritional status
Retinol Binding Protein and Transthyretin dosage
Measured: 48 hours
Essentials amino acid absorption
Area under the curve of plasma concentration
Measured: 48 hours
Insulinemia evolution
Insulinemia dosage
Measured: 48 hours
Link between amino acid and insuline
Correlation coefficient
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalabsorptionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Gautry, MD, Study chair, Nestle Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590120
- Sponsor's protocol ID
- 12.02.FR.NHS
- Acronym
- PEPS
- Status last verified
- Mar 2022
- First submitted
- 27 Oct 2015
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique
- ClinicalTrials.gov ID
- NCT02590120
- Acronym / sponsor ID
- PEPS / 12.02.FR.NHS
- Conditions
- Malabsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
The purpose of this study is to evaluate amino acid absorption with two different type of proteins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition product : product A | Active comparator | Dietary Supplement: Enteral nutritionAdministration during 16 hours. |
| Enteral nutrition product : product B | Active comparator | Dietary Supplement: Enteral nutritionAdministration during 16 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with gastrointestinal disorder : citrulline plasma concentration < 20 µmol/L and/or xylose plasma concentration < 1,7 mmol/L
- Patient under enteral nutrition at home
- Patient already receiving 1 L by day
Key exclusion criteria (4 listed)
- Obese patient BMI > 30
- Diabetes
- Renal or liver failure
- Glucocorticoids treatment
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 |
|---|---|---|
| Enteral nutrition | Dietary supplement | Enteral nutrition product : product A, Enteral nutrition product : product B |
Primary outcome
Amino acid absorption profile
Time frame: 48 hours
Area under the curve of amino acid plasma concentration
5 secondary outcomes
Tolerance
Time frame: 48 hours
Nutritional status
Time frame: 48 hours
Essentials amino acid absorption
Time frame: 48 hours
Insulinemia evolution
Time frame: 48 hours
Link between amino acid and insuline
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
Julien Gautry, MD study chair
Nestle Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition in people with Malabsorption, run by Société des Produits Nestlé (SPN) at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amino acid absorption profile (time frame: 48 hours). 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 15 Apr 2022.