Can Synbiotic Use Effect Gut Bacteria and the Immune Response in Older People
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ClinicalTrials.gov Identifier: NCT01226212 |
Recruitment Status :
Completed
First Posted : October 22, 2010
Last Update Posted : May 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Dietary Supplement: Synbiotic (Synergy 1/B. longum) Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Can Synbiotic Use Improve Dysbiosis in the Gut Microbiome and Modify Inflammatory Processes in Older People |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- Increase in levels of faecal bifidobacteria [ Time Frame: 4 weeks ]
- Improvement in inflammatory markers linked to ageing [ Time Frame: 4 weeks ]
- Improvement in bowel habit and quality of life [ Time Frame: 4 weeks ]
- Reduction of genotoxic potential [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226212
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Professor George Macfarlane, University of Dundee |
ClinicalTrials.gov Identifier: | NCT01226212 |
Other Study ID Numbers: |
2010GA03 Funder ( Other Grant/Funding Number: Chief Scientist Office ETM66 ) |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | May 3, 2013 |
Last Verified: | April 2013 |
Older people Synbiotic Prebiotic |
Probiotic Bacteria Immune |
Sulfalene Anti-Infective Agents Anti-Infective Agents, Urinary Renal Agents |
Antimalarials Antiprotozoal Agents Antiparasitic Agents |