NCT01475942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 27, 2016

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

September 20, 2011

Last Update Submit

January 26, 2016

Conditions

Intestinal C. Difficile

Keywords

elderlyprobioticbowel functionpathogenconstipationdiarrhoeaSubclinical levels

Outcome Measures

Primary Outcomes (1)

  • Change in level of faecal Clostridium difficile

    Quantification of C. difficile from faecal samples

    0 weeks, 8 weeks, 16 weeks

Secondary Outcomes (4)

  • Change in nutritional status

    0 weeks, 16 weeks

  • Change in quality of life

    0 weeks, 16 weeks

  • Change in levels of other intestinal pathogens than C. difficile

    0 weeks, 8 weeks, 16 weeks

  • Change in bowel function

    0 weeks, 16 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Lactobacillus

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Sucrose

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.

Also known as: Lactobacillus
PlaceboProbiotic

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • elderly subjects
  • no acute infection at recruitment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elderly Home Kerttuli

Turku, Finland

Location

MeSH Terms

Conditions

ConstipationDiarrhea

Interventions

ProbioticsLacteol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sampo Lahtinen, PhD

    Danisco

    STUDY CHAIR

  • Anna Lyra, PhD

    Danisco

    STUDY DIRECTOR

  • Matti Viitanen, MD

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

November 22, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 27, 2016

Record last verified: 2015-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)