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

This study has been completed.
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01226212
First received: October 18, 2010
Last updated: May 2, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Synbiotic Use Improve Dysbiosis in the Gut Microbiome and Modify Inflammatory Processes in Older People

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Increase in levels of faecal bifidobacteria [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in inflammatory markers linked to ageing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Improvement in bowel habit and quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Reduction of genotoxic potential [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226212

Locations
United Kingdom
Department of Oncology and Molecular Medicine, Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: George Macfarlane, PhD University of Dundee
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor George Macfarlane, University of Dundee
ClinicalTrials.gov Identifier: NCT01226212     History of Changes
Other Study ID Numbers: 2010GA03, Funder
Study First Received: October 18, 2010
Last Updated: May 2, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Dundee:
Older people
Synbiotic
Prebiotic
Probiotic
Bacteria
Immune

ClinicalTrials.gov processed this record on November 24, 2014