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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01226212
Enrollment
49
Registered
2010-10-22
Start date
2010-11-30
Completion date
2012-12-31
Last updated
2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Older people, Synbiotic, Prebiotic, Probiotic, Bacteria, Immune

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.

Interventions

DIETARY_SUPPLEMENTSynbiotic (Synergy 1/B. longum)

Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum

DIETARY_SUPPLEMENTPlacebo

maltodextrose

Sponsors

Chief Scientist Office of the Scottish Government
CollaboratorOTHER_GOV
University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
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.

Design outcomes

Primary

MeasureTime frame
Increase in levels of faecal bifidobacteria4 weeks

Secondary

MeasureTime frame
Improvement in inflammatory markers linked to ageing4 weeks
Improvement in bowel habit and quality of life4 weeks
Reduction of genotoxic potential4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026