NCT00748748

Brief Summary

Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. The purpose of this study is to examine the safety and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of diarrhea associated with antibiotic use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

September 8, 2008

Last Update Submit

July 3, 2012

Conditions

Antibiotic-associated Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Incidence of diarrhea

    Approximately one month

Study Arms (1)

1

EXPERIMENTAL

Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.

Biological: Culturelle

Interventions

CulturelleBIOLOGICAL

10\^10 Lactobacillus rhamnosus GG per capsule

1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants (male or female inpatients) 18 to 64 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the Fargo VAMC Primary Care Clinic area.
  • Participants must be able to swallow a capsule.

You may not qualify if:

  • Reported recurrent diarrhea
  • Antibiotics in the past four weeks
  • Significant underlying conditions (e.g. diabetes, structural cardiac defects including valvular defects, history of infective endocarditis, poor cardiac function, immunosuppression, impaired gut integrity, moderate or serious intestinal disorders, malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolonged hospitalization)
  • Previous bowel surgery
  • Nutritional restrictions that preclude participation
  • Hypersensitivity to penicillin G, ampicillin, or erythromycin
  • Persons who have been prescribed their antibiotic for a duration longer than 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fargo VA Medical Center

Fargo, North Dakota, 58102, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tze Shien Lo, MD

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

February 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

US(1)