Prebiotics and immunity trial
| ISRCTN | ISRCTN99656583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99656583 |
| Protocol serial number | 8280 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | Beghin-Meiji (France) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Short-chain fructooligosaccharides |
| Primary outcome measure(s) |
Serum anti-vaccine antibodies, measured at weeks 3 and 6 (0 and 3 weeks post-vaccination) |
| Key secondary outcome measure(s) |
1. Blood immune cell subsets, measured at 0, 3 and 6 weeks |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 105 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/09/2010 |
| Date of final enrolment | 30/11/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Medicine
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
