Effect of Multi-species Probiotic HOWARU® Restore, on Gut... | NCT02207140

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

NCT02207140

Sponsor

Gabriella C. van Zanten

Status

Completed

Last Update Posted

Jun 21, 2016Estimated

Enrollment

90Actual

Phase

Early Phase 1

Conditions

Elderly
Probiotics
Clostridium Difficile
Gut Microbiota
Fecal Metabolome

Interventions

HOWARU Restore

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-1-2014-051	Other Identifier	The Scientific Ethics Committee of the Capital Region, Denmark

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jul 31, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2016

Last Update Posted Date

Jun 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
probiotic	Experimental	HOWARU Restore	Dietary Supplement: HOWARU Restore
placebo	Placebo Comparator	microcrystalline cellulose	Dietary Supplement: HOWARU Restore

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HOWARU Restore	Dietary Supplement		placebo probiotic

Measure	Description	Time Frame
Fecal Clostridium difficile numbers		24 weeks

Measure	Description	Time Frame
fecal microbial composition		24 weeks

Measure	Description	Time Frame
fecal metabolome		24 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriella C van Zanten, PhD	University of Copenhagen, Dept. of Food Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen		Frederiksberg C		1958	Denmark