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OpenTrials
Completed

NCT Number: NCT02207140

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

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. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.

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Key information

Conditions

Elderly Clostridium Difficile Fecal Metabolome Gut Microbiota Probiotics

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • aged 75 years or more

Exclusion criteria

  • 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

Treatment and study plan

HOWARU Restore

Dietary Supplement

Primary outcomes

  1. Fecal Clostridium difficile numbers

    Time frame: 24 weeks

Secondary outcomes

  1. fecal microbial composition

    Time frame: 24 weeks

Other outcomes

  1. fecal metabolome

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Gabriella C. van Zanten

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2014
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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