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Completed

NCT Number: NCT00641199

Probiotics for Prevention of Antibiotic-associated Diarrhea

The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5C9, Canada

About this study

A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration.

The proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention of AAD.

In addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. The samples will undergo microbial analysis for routine C & S(Salmonella, Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C. difficile toxin.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-75 years of age
  • Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics

Exclusion criteria

  • Treatment with an antibiotic two weeks prior to study entry
  • Underlying long term gastrointestinal disease (i.e., Ulcerative Colitis, Crohn's Disease, irritable bowel syndrome, ileostomy, colostomy)
  • Pregnant or lactating
  • Immunocompromised state
  • Chronic illness such as Hepatitis B, Hepatitis C, renal failure
  • Inability to provide informed consent, inability to speak or write in English
  • Receiving tube feeds
  • Insufficiently functional (physically and cognitively) to complete the study diary and questionnaires.

Treatment and study plan

Jarro-Dophilus EPS probiotics

Other

Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.

Primary outcomes

  1. Incidence of patients experiencing diarrhea

    Time frame: Duration of antibiotic course plus 3 weeks

Secondary outcomes

  1. Duration of diarrhea

    Time frame: Duration of antibiotic course plus 3 weeks

  2. Quality of life.

    Time frame: Duration of antibiotic course plus 3 weeks

  3. Gastrointestinal Symptom Rating Scale score.

    Time frame: Duration of antibiotic course plus 3 weeks

  4. Incidence of adverse effects.

    Time frame: Duration of antibiotic course plus 3 weeks

  5. Presence of pathogens in fecal samples.

    Time frame: Duration of antibiotic course

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Institut Rosell
  • Jarrow Formulas Inc

Registry information

Official study title

The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2008
Registry last updated
Jan 15, 2010

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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