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OpenTrials
Completed

NCT Number: NCT01254097

Probiotics in Primary Care

Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective 'good' bacteria in the body. This research will test if taking a probiotic with prescribed antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M.S. Hershey Medical Center, Dept of Family and Community Medicine

Hershey, Pennsylvania, 17033, United States

About this study

Objectives Several studies have demonstrated that probiotics can be helpful in preventing antibiotic-associated diarrhoea in hospitalized patients. However, the extent to which probiotics may benefit healthy adults taking a course of antibiotics has not been investigated in primary care. Furthermore, patient willingness to take a probiotic supplement concomitantly with antibiotics has not been explored. We aimed to conduct an exploratory study using probiotics in adults requiring an acute course of antibiotic therapy.

Methods Patients prescribed antibiotics for treatment of acute infections in an outpatient family practice setting were randomized to receive either a probiotic or placebo concurrently. Patients completed adherence diaries and daily symptom checklists to assess gastrointestinal and vaginal (women) symptoms and collect information about adherence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults 18 - 79 years of age with infection requiring an oral antibiotic.
  • Must be able to be contacted via telephone.

Exclusion criteria

  • pregnancy,
  • breast-feeding,
  • those receiving tube feeding,
  • those with diarrhea as a current symptom of present illness, and pre-existing illnesses that contribute to diarrhea such as inflammatory bowel disease,
  • irritable bowel syndrome, colitis or celiac disease.
  • Those undergoing active cancer treatments with chemotherapeutic or radiation therapy,
  • immunocompromised persons,
  • history of cardiac valvular disease,
  • those taking a laxative or stool softener on a daily basis, as well as
  • persons treated with an antibiotic in the previous 60 days,
  • new antibiotic prescription that exceeds a 10 day course, or regular use of a probiotic within the previous three weeks (including daily ingestion of yogurt).

Treatment and study plan

Probiotic

Dietary Supplement

Probiotic capsule, 2 capsules twice daily

Other names: Florajen 3

Primary outcomes

  1. Rate of antibiotic associated diarrhea

    Time frame: two weeks after start of antibiotics

    Groups will be compared based on rates of antibiotic associated diarrhea, symptoms developing in the two week window of when antibiotics are started.

Secondary outcomes

  1. Participant knowledge of probiotics

    Time frame: At participant recruitment

    Assess current knowledge of probiotics of participants at the time of recruitment to study

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Feasibility Study of Probiotics in Primary Care

Important dates

Study start
2011
Primary completion
2011
Study completion
2014
First posted
Dec 6, 2010
Registry last updated
Sep 25, 2015

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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