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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207140
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriella C. van Zanten, University of Copenhagen

Study Description
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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. 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.

Condition or disease Intervention/treatment Phase
Elderly Probiotics Clostridium Difficile Gut Microbiota Fecal Metabolome Dietary Supplement: HOWARU Restore Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: probiotic
HOWARU Restore
 Dietary Supplement: HOWARU Restore
Placebo Comparator: placebo
microcrystalline cellulose
 Dietary Supplement: HOWARU Restore


Outcome Measures
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Primary Outcome Measures :
  1. Fecal Clostridium difficile numbers [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. fecal microbial composition [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. fecal metabolome [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207140


Locations
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Denmark
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
Gabriella C. van Zanten
Investigators
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Principal Investigator: Gabriella C van Zanten, PhD University of Copenhagen, Dept. of Food Science
More Information
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Responsible Party: Gabriella C. van Zanten, Postdoc, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02207140    
Other Study ID Numbers: DKID H-1-2014-051
H-1-2014-051 ( Other Identifier: The Scientific Ethics Committee of the Capital Region, Denmark )
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016