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CompletedNCT02207140Updated Jun 21, 2016

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

An Early Phase 1 interventional study of HOWARU Restore in Elderly, Probiotics and Clostridium Difficile, sponsored by Gabriella C. van Zanten. Completed at 1 site in Denmark. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-21.

Sponsored by Gabriella C. van Zanten · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Elderly
  • Probiotics
  • Clostridium Difficile
  • Gut Microbiota
  • Fecal Metabolome
03

In context

Lead sponsor

This is the only study on the registry with Gabriella C. van Zanten as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy
  • aged 75 years or more

Exclusion criteria

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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    probiotic

    HOWARU Restore

    Dietary Supplement: HOWARU Restore

  • Placebo comparator
    placebo

    microcrystalline cellulose

    Dietary Supplement: HOWARU Restore

Interventions

  • Dietary supplementHOWARU Restore
06

What researchers measure

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

07

Study locations

1 site
  • Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
    Frederiksberg C, 1958, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02207140
Lead sponsor
Gabriella C. van Zanten
Responsible party
Gabriella C. van Zanten (Postdoc, University of Copenhagen) — Sponsor-investigator
First posted
Aug 4, 2014
Start date
Oct 2014
Primary completion
May 2016
Completion
May 2016
Last update
Jun 21, 2016

Study contacts

Gabriella C van Zanten, PhD
principal investigator · University of Copenhagen, Dept. of Food Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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