Can Synbiotic Use Effect Gut Bacteria and the Immune Response in Older People
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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 |
- Increase in levels of faecal bifidobacteria [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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 |
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| United Kingdom | |
| Department of Oncology and Molecular Medicine, Ninewells Hospital and Medical School | |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Principal Investigator: | George Macfarlane, PhD | University of Dundee |
More Information
Publications:
| 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 |
Additional relevant MeSH terms:
|
Sulfalene Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Urinary |
Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 19, 2013