Prebiotics and immunity trial
| ISRCTN | ISRCTN99656583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99656583 |
| Secondary identifying numbers | 8280 |
- Submission date
- 26/11/2010
- Registration date
- 26/11/2010
- Last edited
- 09/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Philip Calder
Scientific
Scientific
School of Medicine
IDS Building, Mail Point 887
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 23 8059 5000 |
|---|---|
| pcc@soton.ac.uk |
Study information
| Study design | Single-centre randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A placebo-controlled, double-blind, randomised study to evaluate the efficacy of fructo-oligosaccharides on the immune response in elderly people |
| 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(s) | Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 02/03/2010, ref: 10/H0501/1 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Short-chain fructooligosaccharides |
| Primary outcome measure | 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 study start date | 06/09/2010 |
| Overall study end date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 105; UK sample size: 105 |
| 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 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
- England
- United Kingdom
Study participating centre
School of Medicine
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Resarch and Development Office
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.suht.nhs.uk/home.aspx |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Industry
Beghin-Meiji (France)
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/12/2019: The intention to publish date has been added.
06/12/2019: No publications found, verifying study status with principal investigator.
23/05/2017: No publications found in PubMed, verifying study status with principal investigator
