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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226212
• Other study ID #: 2010GA03
• Secondary ID: Funder
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: May 2, 2013
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Synbiotic (Synergy 1/B. longum)
Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum
• Placebo
maltodextrose

Locations

Country	Name	City	State
United Kingdom	Department of Oncology and Molecular Medicine, Ninewells Hospital and Medical School	Dundee	Tayside

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Bartosch S, Fite A, Macfarlane GT, McMurdo ME. Characterization of bacterial communities in feces from healthy elderly volunteers and hospitalized elderly patients by using real-time PCR and effects of antibiotic treatment on the fecal microbiota. Appl Environ Microbiol. 2004 Jun;70(6):3575-81. — View Citation

Furrie E, Macfarlane S, Kennedy A, Cummings JH, Walsh SV, O'neil DA, Macfarlane GT. Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial. Gut. 2005 Feb;54(2):242-9. — View Citation

Macfarlane GT, Steed H, Macfarlane S. Bacterial metabolism and health-related effects of galacto-oligosaccharides and other prebiotics. J Appl Microbiol. 2008 Feb;104(2):305-44. doi: 10.1111/j.1365-2672.2007.03520.x. Review. — View Citation

Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Review. — View Citation

Steed H, Macfarlane GT, Blackett KL, Bahrami B, Reynolds N, Walsh SV, Cummings JH, Macfarlane S. Clinical trial: the microbiological and immunological effects of synbiotic consumption - a randomized double-blind placebo-controlled study in active Crohn's disease. Aliment Pharmacol Ther. 2010 Oct;32(7):872-83. doi: 10.1111/j.1365-2036.2010.04417.x. — View Citation

Woodmansey EJ, McMurdo ME, Macfarlane GT, Macfarlane S. Comparison of compositions and metabolic activities of fecal microbiotas in young adults and in antibiotic-treated and non-antibiotic-treated elderly subjects. Appl Environ Microbiol. 2004 Oct;70(10):6113-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in levels of faecal bifidobacteria		4 weeks	No
Secondary	Improvement in inflammatory markers linked to ageing		4 weeks	No
Secondary	Improvement in bowel habit and quality of life		4 weeks	No
Secondary	Reduction of genotoxic potential		4 weeks	No