Can Synbiotic Use Effect Gut Bacteria and the Immune Response in Older People

Sponsor

University of Dundee (Other)

Overall Status

Completed

CT.gov ID

NCT01226212

Collaborator

Chief Scientist Office of the Scottish Government (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are to use a nutritional change in the diet to improve gut health in older people. Ageing can result in major changes in the composition and activities of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections, decreased intestinal motility and impaired bowel function as people get older. This can result in constipation or diarrhoea, increased levels of inflammation and reduced immune response to infection. Therefore, individuals aged 65 or over could benefit from safe and effective interventions that maintain a healthy balance of gut bacteria as well as restoring the immune response. Bacteria in the gut are known to promote health. Eating foods containing beneficial bacteria for example (probiotics) or food which contain substrates for the bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators will use a synbiotic with known anti-inflammatory properties, comprising a probiotic Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in the gut in two studies in patients with inflammatory bowel disease. The investigators would now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and immune function of older individuals in a double-blinded, crossover, placebo controlled, randomised investigation involving 40 volunteers for three months. The trial is designed so that participants will be assigned to receive the Synbiotic preparation or the placebo for the first four weeks, this will be followed by four weeks without treatment, and then they will switch to the opposite preparation for another four weeks.

Condition or Disease	Intervention/Treatment	Phase
Aging	Dietary Supplement: Synbiotic (Synergy 1/B. longum) Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Can Synbiotic Use Improve Dysbiosis in the Gut Microbiome and Modify Inflammatory Processes in Older People

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Synbiotic Synbiotic (Synergy 1/B. longum)	Dietary Supplement: Synbiotic (Synergy 1/B. longum) Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum
Placebo Comparator: Placebo maltodextrose	Dietary Supplement: Placebo maltodextrose

Arm

Intervention/Treatment

Experimental: Synbiotic

Synbiotic (Synergy 1/B. longum)

Dietary Supplement: Synbiotic (Synergy 1/B. longum)

Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum

Placebo Comparator: Placebo

maltodextrose

Dietary Supplement: Placebo

maltodextrose

Outcome Measures

Primary Outcome Measures

Increase in levels of faecal bifidobacteria [4 weeks]

Secondary Outcome Measures

Improvement in inflammatory markers linked to ageing [4 weeks]
Improvement in bowel habit and quality of life [4 weeks]
Reduction of genotoxic potential [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

65-90 years
BMI 18.5-30.0 kg m2.

Exclusion Criteria:

asplenia and other acquired or congenital immunodeficiencies
any autoimmune disease
connective tissue diseases
self-reported symptoms of acute or recent infection (including use of antibiotics within the previous 3 months)
taking probiotics or prebiotics, including lactulose for constipation
chronic gastrointestinal problems (e.g. Inflammatory bowel disease, irritable bowel syndrome, cancer)
use of immunosuppressive or anti-inflammatory drugs.