Immune Benefits of WGP in Elderly | NCT02262091

Studies
Immune Benefits of WGP in Elderly

NCT02262091

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Elderly People

Interventions

Food fibers
Maltodextrin
Influenza vaccine (incl. criterion)

Countries

Germany

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

Sep 2014

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

Aug 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 8, 2013

First Submission Date that Met QC Criteria

Oct 7, 2014

First Posted Date

Oct 10, 2014Estimated

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 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

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

150Estimated

Label	Type	Description	Intervention Names
Placebo group	Placebo Comparator		Dietary Supplement: Maltodextrin Biological: Influenza vaccine (incl. criterion)
Food fibers	Experimental		Dietary Supplement: Food fibers Biological: Influenza vaccine (incl. criterion)

Name	Type	Description	Arm Group Labels	Other Names
Food fibers	Dietary Supplement		Food fibers
Maltodextrin

Measure	Description	Time Frame
Change from baseline at 4 weeks post-vaccination in antibody titers levels		Up to 1 month

Measure	Description	Time Frame
Measure of seroconversion		Up to 2 months
Measure of cytokines production		Up to 2 months 2014
Measure the occurence of clinical endpoints

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female elderly volunteers equal or above age of 70
Pre-frail and frail subjects (based on Fried's criteria)
Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
Having obtained his/her (or his/her legal representative's) informed consent

Exclusion Criteria:

Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
Allergy to eggs or influenza vaccine components.
Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
Subject who has taken antibiotics in the last 2 months prior to entering the study.
Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
Personal or family history of Guillain-Barre syndrome
BMI>35 kg/m2
Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
Subject who cannot be expected to comply with the study procedures
Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Leiter des Geriatrischen Zentrums Oldenburg (GZO)		Oldenburg		26133	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28694834	Derived	Bauer JM, De Castro A, Bosco N, Romagny C, Diekmann R, Benyacoub J, Vidal K. Influenza vaccine response in community-dwelling German prefrail and frail individuals. Immun Ageing. 2017 Jul 6;14:17. doi: 10.1186/s12979-017-0098-z. eCollection 2017.

ID	Term
C008315	maltodextrin
D007252	Influenza Vaccines

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures