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Prebiotics and immunity trial

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99656583
Enrollment
105
Registered
2010-11-26
Start date
2010-09-06
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Inflammatory and Immune System, Primary Care Research Network for England

Interventions

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

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026