Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans (NCT01218165) | Clinical Trial Compass
CompletedEarly Phase 1
Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
Germany48 participantsStarted 2010-05
Plain-language summary
Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.
Who can participate
Age range
65 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men \>65 years of age.
* Body mass index: 22-34,9 kg/m²
* non-smokers
Intervention trial:
* hsCRP \> 1 mg/L (Screening blood test)
* normal blood count (Screening blood test)
* normal ALAT, ASAT and serum creatinine levels (Screening blood test)
Exclusion Criteria:
* any major non-organic disease, including malign diseases (haematological, inflammatory, metabolic,)
* any major organ disease, including neoplastic diseases.
* intake of antibiotics within the last 6 weeks
* chronic therapy with analgetics (incl. acetylsalicylic acid)
* chronic therapy with proton pump inhibitors
* regular intake of probiotic bacteria products within the last 3 weeks
* chronic anti-inflammatory therapy with NSARs or previous therapy within the last 20 days
* subjects with expected non-compliance to protocol guidelines
* subjects that participate in other trials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.