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

NCT02207140 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-06-21

No results posted yet for this 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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

HOWARU Restore

Sponsors & Collaborators

  • Gabriella C. van Zanten

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207140 on ClinicalTrials.gov