utrition effects on oral vaccinatio
Completed
- Conditions
- Mucosal immunology and nutritionNutritional, Metabolic, EndocrineNutrition
- Registration Number
- ISRCTN68751738
- Lead Sponsor
- Queen Mary University of London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Residence in ongoing cohort study area in Misisi township, Lusaka
2. Aged greater than 18 years, either sex
Exclusion Criteria
1. Helminth infection
2. Pregnancy
3. Breastfeeding
4. Aged greater than 65 years
5. Diarrhoea within one month prior to recruitment
6. Medication with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within one month prior to recruitment
7. Any vaccination within 6 months prior to recruitment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expression of antimicrobial peptides and cytokines in micronutrient recipients compared to placebo. <br><br>Enteroscopy will be carried out on day 0 (the day of immunisation), which will be after the participant has been receiving the micronutrient supplement or placebo for 2 months) and then again at one specific time point after that (undecided as of 25/02/2009). The purpose of enteroscopy is to obtain seven biopsies from the jejunum which will be processed for analysis of messenger ribonucleic acid (mRNA), antimicrobial peptides and cytokines by real time polymerase chain reaction (RT-PCR).
- Secondary Outcome Measures
Name Time Method Response of peripheral blood mononuclear cells to vaccine antigens in vitro in micronutrient recipients compared to placebo. <br><br>Blood will be collected on the same day as the the enteroscopy and peripheral blood mononuclear cells (PBMCs) prepared by Ficoll centrifugation. An assay of mRNA will be by RT-PCR.