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Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status and phase

Completed
Early Phase 1

Conditions

Healthy
Aged

Treatments

Other: Control Group
Dietary Supplement: Probiotic drink

Study type

Interventional

Funder types

Other

Identifiers

NCT01218165
EA1/062/10

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

Male

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Control Group
No Intervention group
Description:
without intervention
Treatment:
Other: Control Group
Intervention Group
Experimental group
Description:
This group receives a probiotic drink daily for 6 week.
Treatment:
Dietary Supplement: Probiotic drink

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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