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OpenTrials
Completed

NCT Number: NCT00748748

Effect of Lactobacillus Probiotic on Healthy Adults

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.

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fargo VA Medical Center

Fargo, North Dakota, 58102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Exclusion criteria include diarrhea on admission or within the preceding week
  • 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

Treatment and study plan

Culturelle

Biological

10^10 Lactobacillus rhamnosus GG per capsule

Primary outcomes

  1. Incidence of diarrhea

    Time frame: Approximately one month

Sponsors and collaborators

Lead sponsor

Fargo VA Medical Center

Fed

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2008
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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