Clinical trial NCT01218165: Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
Official title: The Inflammaging Network: Bridging Low Grade Inflammation With Gut Microbiota and Intestinal Barrier Function in Elderly Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Aged
Healthy
Keywords: Healthy Eldery People
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 48
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre/post-intervention change in hsCRP
timeFrame: 6 weeks
Secondary outcomes:
measure: Intestinal permeability
timeFrame: 6 weeks
measure: Stool: Stool: Real-Time-PCR
timeFrame: 6 weeks
measure: Blood screening
timeFrame: 6 weeks
measure: Muscle function
timeFrame: 6 weeks
measure: Physical performance status
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Luzia Valentini, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Innsbruck
name: Herbert Lochs, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Jörg-Dieter Schulzke, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Stefan Bereswill, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Alexander Swidsinski, Doctor
role: PRINCIPAL_INVESTIGATOR
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