NCT02207140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

July 31, 2014

Last Update Submit

June 20, 2016

Conditions

ElderlyProbioticsClostridium DifficileGut MicrobiotaFecal Metabolome

Outcome Measures

Primary Outcomes (1)

  • Fecal Clostridium difficile numbers

    24 weeks

Secondary Outcomes (1)

  • fecal microbial composition

    24 weeks

Other Outcomes (1)

  • fecal metabolome

    24 weeks

Study Arms (2)

probiotic

EXPERIMENTAL

HOWARU Restore

Dietary Supplement: HOWARU Restore

placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: HOWARU Restore

Interventions

HOWARU RestoreDIETARY_SUPPLEMENT
placeboprobiotic

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy
  • aged 75 years or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Frederiksberg C, 1958, Denmark

Location

Study Officials

  • Gabriella C van Zanten, PhD

    University of Copenhagen, Dept. of Food Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 4, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

DK(1)