Probiotic, Prebiotic and Synbiotic Effect on Immunity

Dietary Intervention Clinical Trial

Official title:

Double-blind, Placebo Controlled Randomized Parallel Study to Determine the Effects of Pre-pro and Synbiotic Administration on the Immune Response to Influenza Vaccination and Faecal Microbiota in Healthy Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01084434
• Other study ID #: F3168407
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2010
• Last updated: March 9, 2010
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2010
• Source: University of Reading
• Contact: Maria Magdalena Baran, MSc
• Phone: 0044118 378 6217
• Email: m.m.baran[@]reading.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the effect of dietary supplements such as probiotic, prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota in adult healthy volunteers.

Description:

Within recent times, influenza has become a major respiratory infection worldwide. The preventative vaccination reduces the severity of infection but ageing reduced its efficacy and it is only effective in 17-53% in elderly individuals. Thus, nutritionists and medical researchers are looking for opportunities to improve the immune response to influenza vaccine. Functional foods, such as probiotics, prebiotics and synbiotics, apart from other health benefits, may contribute towards immune protection.

Probiotics are beneficial bacteria, which are regarded as safe and serve health benefits to the host, while prebiotics are carbohydrates which by escaping digestion in the upper gastrointestinal tract may reach the colon and there serve as food for beneficial bacteria in the colon. When prebiotic used in combination with probiotic bacteria, it is called synbiotic, and it may improve survival and implantation of probiotic in the gut.

The human study will examine the immune response to vaccination and changes in faecal microbiota during administration of probiotic, prebiotic and synbiotic supplements. The study will be conducted between vaccinations seasons in 2010-2011 and recruit 100 healthy subjects aged 40-65years old. Participant will be given one of four different treatments over a 7 week period following 3 weeks of wash-out period. Treatments given include: a probiotic, a prebiotic, a synbiotic and a placebo. In the 3rd week of product consumption the participant will be given a flu jab. Specific antibody titre against the 3 viral strains composing the vaccine and total immunoglobulin concentration in the serum will be monitored during 2 and 4 weeks after vaccination. Faecal samples and saliva will be collected and analysed for changes in faecal microbial populations.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed consent form

• Age 40-65 years

• Body mass index 18.5-30 inclusive

• Good general health as determined by medical questionnaires

• Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine

Exclusion Criteria:

• Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study

• History of drug misuse, including alcohol

• Allergy to the vaccine

• Asplenia and other acquired or congenital immunodeficiency

• Severe allergy such as asthma, hay-fever, dermatitis or being treated on these

• History of severe abnormal drug reaction

• Any autoimmune disease

• Diabetic (type 1 or type2)

• Food allergy manifested by gastrointestinal, skin, respiratory , neurological, anaphylaxis symptoms

• Lactose intolerance showed by clinical symptoms such as nausea, cramping, bloating, diarrhea and flatulence after consuming lactose containing dairy products (milk, yoghurt, butter, cheese, ice-cream, sour cream) or lactose non-dairy products ( whey, milk solids, modified milk ingredients)

• Participation in experimental drug trial within four weeks prior to study

• Participation in prebiotics or laxative trial within the previous three months

• Use of antibiotics within the previous six months

• Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint

• Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study

• Use of prescribed medication

• Regular use of aspirin or other anti-inflammatory drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Intervention

Intervention

Dietary Supplement:
• probiotic
Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks
• prebiotic
Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
• Synbiotic
(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
• Placebo
Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks

Locations

Country	Name	City	State
United Kingdom	University of Reading, Food and Nutritional Sciences Department	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group.		2 and 4 weeks after vaccination	No
Secondary	The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities.		at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment	No