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CompletedNCT02590120PEPSUpdated Apr 15, 2022

Enteral Nutrition and Amino Acid Absorption

An interventional study of Enteral nutrition in Malabsorption, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-15.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2015, registered Oct 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate amino acid absorption with two different type of proteins.

02

Conditions studied

  • Malabsorption
03

In context

Malabsorption Syndromes

54 studies on the registry are indexed under Malabsorption Syndromes; 12 are open to participants now.

This study's enrollment of 6 is below the median of 38 across 44 interventional studies indexed under Malabsorption Syndromes.

Browse Malabsorption Syndromes studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Obese patient > 30
  • Diabetes
  • Renal or liver failure
  • treatment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Active comparator
    Enteral nutrition product : product A

    Administration during 16 hours.

    Dietary Supplement: Enteral nutrition

  • Active comparator
    Enteral nutrition product : product B

    Administration during 16 hours.

    Dietary Supplement: Enteral nutrition

Interventions

  • Dietary supplementEnteral nutrition
06

What researchers measure

Primary outcomes

  1. Amino acid absorption profile

    Area under the curve of amino acid plasma concentration

    Time frame: 48 hours

Secondary outcomes

  1. Tolerance

    Description and occurence of adverse events

    Time frame: 48 hours

  2. Nutritional status

    Retinol Binding Protein and Transthyretin dosage

    Time frame: 48 hours

  3. Essentials amino acid absorption

    Area under the curve of plasma concentration

    Time frame: 48 hours

  4. Insulinemia evolution

    Insulinemia dosage

    Time frame: 48 hours

  5. Link between amino acid and insuline

    Correlation coefficient

    Time frame: 48 hours

07

Study locations

1 site
  • CHU de Lille
    Lille, 59037, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02590120
Responsible party
Sponsor
First posted
Oct 28, 2015
Start date
Feb 2015
Primary completion
Dec 2021
Completion
Dec 2021
Last update
Apr 15, 2022

Study contacts

Julien Gautry, MD
study chair · Nestle Health Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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