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OpenTrials
Completed

NCT Number: NCT01226212

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

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.

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Key information

Conditions

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology and Molecular Medicine, Ninewells Hospital and Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synbiotic (Synergy 1/B. longum)

Dietary Supplement

Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum

Placebo

Dietary Supplement

maltodextrose

Primary outcomes

  1. Increase in levels of faecal bifidobacteria

    Time frame: 4 weeks

Secondary outcomes

  1. Improvement in inflammatory markers linked to ageing

    Time frame: 4 weeks

  2. Improvement in bowel habit and quality of life

    Time frame: 4 weeks

  3. Reduction of genotoxic potential

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 22, 2010
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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