Probiotic, Prebiotic and Synbiotic Effect on Immunity

NCT01084434 | Unknown

• 1 other identifier: F3168407
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dietary Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (4)

Probiotic group

EXPERIMENTAL

Group of 25 volunteers consuming probiotic product once a day for 7 weeks

Dietary Supplement: probiotic

Prebiotic group

EXPERIMENTAL

Group of 25 volunteers consuming prebiotic product once a day for 7 weeks

Dietary Supplement: prebiotic

Synbiotic group

EXPERIMENTAL

Group of 25 volunteers consuming synbiotic product once a day for 7 weeks.

Dietary Supplement: Synbiotic

Placebo group

PLACEBO COMPARATOR

Group of 25 volunteers consuming placebo product once a day for 7 weeks

Dietary Supplement: Placebo

Interventions

probiotic DIETARY_SUPPLEMENT

Bifidobacterium lactis HN019 10\^9 CFU/day 1 sachet once a day for 7 weeks

Also known as: HOWARU Bifidobacterium lactis

Probiotic group

prebiotic DIETARY_SUPPLEMENT

Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks

Also known as: Bimuno

Prebiotic group

Synbiotic DIETARY_SUPPLEMENT

(Bifidobacterium lactis 10\^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks

Synbiotic group

Placebo DIETARY_SUPPLEMENT

Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks

Placebo group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading, Food and Nutritional Sciences Department

Reading, Berkshire, RG66AP, United Kingdom

Location

MeSH Terms

Interventions

Probiotics; Prebiotics; Synbiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Maria Magdalena Baran, MSc

  PRINCIPAL INVESTIGATOR

• Sofia Kolida, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Magdalena Baran, MSc

CONTACT

0044118 378 6217; m.m.baran@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: March 10, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 10, 2010

Record last verified: 2010-02

Locations

GB (1)