Enteral Nutrition and Amino Acid Absorption | NCT02590120

Studies
Enteral Nutrition and Amino Acid Absorption

NCT02590120

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 15, 2022Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Malabsorption

Interventions

Enteral nutrition

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2021Actual

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 27, 2015

First Posted Date

Oct 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2022

Last Update Posted Date

Apr 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral nutrition product : product A	Active Comparator	Administration during 16 hours.	Dietary Supplement: Enteral nutrition
Enteral nutrition product : product B	Active Comparator	Administration during 16 hours.	Dietary Supplement: Enteral nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral nutrition	Dietary Supplement		Enteral nutrition product : product A Enteral nutrition product : product B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amino acid absorption profile	Area under the curve of amino acid plasma concentration	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Tolerance	Description and occurence of adverse events	48 hours
Nutritional status	Retinol Binding Protein and Transthyretin dosage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Obese patient BMI > 30
Diabetes
Renal or liver failure
Glucocorticoids treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julien Gautry, MD	Nestle Health Science	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Lille		Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D008286	Malabsorption Syndromes

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided