Probiotic Intervention With Elderly Subjects | NCT01475942

Studies
Probiotic Intervention With Elderly Subjects

NCT01475942

Sponsor

Danisco

Status

Completed

Last Update Posted

Jan 27, 2016Estimated

Enrollment

104Actual

Phase

Phase 2

Conditions

Intestinal C. Difficile

Interventions

Probiotic

Countries

Finland

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

Status Module

Record Verification Date

Feb 2015

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

Jan 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

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

Jan 26, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Name	Class
University of Turku	OTHER

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 objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.

Detailed Description

The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Active Comparator	Lactobacillus	Dietary Supplement: Probiotic
Placebo	Placebo Comparator	Sucrose	Dietary Supplement: Probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.	Placebo Probiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in level of faecal Clostridium difficile	Quantification of C. difficile from faecal samples	0 weeks, 8 weeks, 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in nutritional status	Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.	0 weeks, 16 weeks
Change in quality of life	Evaluated according to the validated 15D© health related survey from adequately oriented subjects.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elderly subjects
no acute infection at recruitment

Exclusion Criteria:

antibiotic treatment 1 month prior to beginning of study
less than 6 month life expectancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 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
Sampo Lahtinen, PhD	Danisco	Study Chair
Anna Lyra, PhD	Danisco	Study Director
Matti Viitanen, MD	University of Turku	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elderly Home Kerttuli		Turku			Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics
C100843	Lacteol

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided