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

June 20, 2016 updated by: Gabriella C. van Zanten
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: probiotic
HOWARU Restore
Dietary supplement: HOWARU Restore
PLACEBO_COMPARATOR: placebo
microcrystalline cellulose
Dietary supplement: HOWARU Restore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal Clostridium difficile numbers
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
fecal microbial composition
Time Frame: 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
fecal metabolome
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gabriella C. van Zanten

Investigators

  • Principal Investigator: Gabriella C van Zanten, PhD, University of Copenhagen, Dept. of Food Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (ESTIMATE)

August 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DKID H-1-2014-051
  • H-1-2014-051 (OTHER: The Scientific Ethics Committee of the Capital Region, Denmark)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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