Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosu... | NCT01048567

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient resources to meet enrollment target

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

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

Dec 17, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Name	Class
Jamieson Laboratories Ltd, Canada	UNKNOWN
Canadian Society of Hospital Pharmacists	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 purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.

Detailed Description

Antibiotic-associated diarrhea (AAD) is a common adverse drug reaction, occurring in 5-35% of patients, and is of significant consequence to hospitalized patients. Patients who develop AAD are more likely to experience a longer hospital stay, incur higher medical costs, and develop other co-morbidities. Clostridium difficile infection (CDI) accounts for approximately 15-25% of AAD cases and is a significant cause of morbidity and mortality in hospitalized geriatric patients.

A preventative measure that has been suggested for AAD and CDI is the use of probiotics. Although probiotics have been used for a wide range of indications, including the prevention and treatment of AAD and CDI, there is lack of data regarding efficacy of these products.

Hospitalized elderly patients are at significant risk of developing AAD and CDI and prevention of AAD and CDI in this population may contribute to a reduction in morbidity, length of hospital stay, medical costs, and potentially mortality.

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactobacillus acidophilus/rhamnosus	Active Comparator		Other: Lactobacillus acidophilus/rhamnosus
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus acidophilus/rhamnosus	Other	2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy	Lactobacillus acidophilus/rhamnosus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AAD defined as 3 or more loose stools in a 24 hour period.		Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose

Secondary Outcomes

Measure	Description	Time Frame
Incidence of CDI as detected by a stool assay (detection of toxins A or B)		Measured if diarrhea develops in hospital during antibiotic treatment or during the 3 weeks following last antibiotic dose
Duration of hospital stay		Day of hospital admission until day of discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inpatients over the age of 60 on 4A/B unit at Victoria General Hospital, Victoria BC, and
Anticipated to receive antibiotics (intravenous or oral) for greater than 72 hours for any indication, and
Are determined to be competent by the prescriber.

Exclusion Criteria:

Patients who have been on antibiotics during the past 2 weeks
Patients who have active diarrhea at enrollment
Patients who have been diagnosed with CDI within the previous 3 months
Patients who are lactose intolerant
Patients who have an underlying chronic GI tract disease (inflammatory bowel disease, irritable bowel syndrome)
Patients who have an ileostomy or colostomy
Patients who regularly take probiotics
Patients who are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year)
Patients who have a life-threatening illness
Patients who cannot take medications by mouth or are tube fed
Patients who have been on the new antibiotic for more than 72 hours
Patients who are anticipated to receive the new antibiotic for a duration of less than 72 hours
Patients who do no give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Curtis Harder, BSc. Pharm, ACPR, Pharm D	Vancouver Island Health Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority		Victoria	British Columbia	V8Z 6R5	Canada

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