Prebiotics and immunity trial

Phase 1

Completed

• Conditions: 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; Haematological Disorders; Immune response

• Registration Number: ISRCTN99656583
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-26
• Study Completion: 2010-11-30
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified