Status:

COMPLETED

Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly

Lead Sponsor:

Gabriella C. van Zanten

Conditions:

Elderly

Probiotics

Eligibility:

All Genders

75+ years

Phase:

EARLY_PHASE1

Brief Summary

The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fec...

Eligibility Criteria

Inclusion

  • Healthy
  • aged 75 years or more

Exclusion

  • Individuals with chronic bowel diseases
  • Individuals with severe immunosuppression
  • Individuals with dementia
  • Individuals who are terminally ill
  • If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
  • Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
  • Subjects with a history of substance abuse
  • Subjects that, in the investigators opinion, are not expected to complete the study succesfully

Key Trial Info

Start Date :

October 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2016

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT02207140

Start Date

October 1 2014

End Date

May 1 2016

Last Update

June 21 2016

Active Locations (1)

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1

Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen

Frederiksberg C, Denmark, 1958