Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2014-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo group
Maltodextrin
Influenza vaccine (incl. criterion)
Food fibers
Food fibers
Influenza vaccine (incl. criterion)
Interventions
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Food fibers
Maltodextrin
Influenza vaccine (incl. criterion)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Leiter des Geriatrischen Zentrums Oldenburg (GZO)
Oldenburg, , Germany
Countries
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References
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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.
Other Identifiers
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12.22.NRC
Identifier Type: -
Identifier Source: org_study_id
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