Condition category
Haematological Disorders
Date applied
26/11/2010
Date assigned
26/11/2010
Last edited
10/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philip Calder

ORCID ID

Contact details

School of Medicine
IDS Building
Mail Point 887
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
pcc@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8280

Study information

Scientific title

A placebo-controlled, double-blind, randomised study to evaluate the efficacy of fructo-oligosaccharides on the immune response in elderly people

Acronym

Study hypothesis

Prebiotics may improve immune function in humans, but this is a poorly researched area. We will investigate the effect of short chain fructooligosaccharides on aspects of immune function, including response to seasonal influenza vaccination in healthy subjects aged over 65 years. The study will be randomised and controlled and the intervention period will be six weeks.

Ethics approval

Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 02/03/2010, ref: 10/H0501/1

Study design

Single-centre randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Inflammatory and Immune System, Primary Care Research Network for England; Subtopic: Not Assigned, Inflammatory and Immune System (all Subtopics); Disease: Immunology and inflammation, All Diseases

Intervention

Placebo: Maltodextrin, 4 g twice daily, 6 weeks, no follow-up beyond this
Active: Short-chain fructooligosachharide, 4 g twice daily, 6 weeks, no follow-up beyond this

Study entry: registration and one or more randomisations

Intervention type

Drug

Phase

Phase I/II

Drug names

Short-chain fructooligosaccharides

Primary outcome measures

Serum anti-vaccine antibodies, measured at weeks 3 and 6 (0 and 3 weeks post-vaccination)

Secondary outcome measures

1. Blood immune cell subsets, measured at 0, 3 and 6 weeks
2. Ex vivo T-cell responses, measured at 0, 3 and 6 weeks
3. Faecal bacteria counts, measured at 0, 3 and 6 weeks
4. Salivary IgA, measured at 0, 3 and 6 weeks

Overall trial start date

06/09/2010

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years or older, either sex
2. In general good health
3. Body mass index 20 to 32 kg/m2
4. Not consuming probiotic supplements, yoghurts, drinks or other foods
5. Not consuming prebiotic supplemented drinks or foods
6. No antibiotic use in the 2 months prior to entering the study or during the study
7. Not already have received the 2010/2011 seasonal influenza vaccine
8. Willing to receive the seasonal influenza vaccination
9. Being able to provide written informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 105; UK sample size: 105

Participant exclusion criteria

1. Aged less than 65 years
2. Body mass index less than 20 or greater than 32 kg/m2
3. Being diabetic (type 1 or type 2)
4. Being egg allergic
5. Use of prescribed medicine to control inflammation or immune dysfunction
6. Chronic gastrointestinal problems (e.g. IBD, IBS, celiac disease, cancer)
7. Participation in another clinical trial
8. Use of prebiotic or probiotic supplements, foods or drinks
9. Consuming high-dose vitamin, mineral or fish oil supplements
10. Use of antibiotics within the previous two months
11. Previously vaccinated with the seasonal influenza vaccine

Recruitment start date

06/09/2010

Recruitment end date

30/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Resarch and Development Office
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.suht.nhs.uk/home.aspx

Funders

Funder type

Industry

Funder name

Beghin-Meiji (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes