Probiotics for Prevention of Antibiotic-associated Diarrhea

Antibiotic-Associated Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641199
• Other study ID #: PAAD-07-112
• Secondary ID: 07-112
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: January 14, 2010
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic-Associated Diarrhea
• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Institut Rosell, Jarrow Formulas Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients experiencing diarrhea		Duration of antibiotic course plus 3 weeks	No
Secondary	Duration of diarrhea		Duration of antibiotic course plus 3 weeks	No
Secondary	Quality of life.		Duration of antibiotic course plus 3 weeks	No
Secondary	Gastrointestinal Symptom Rating Scale score.		Duration of antibiotic course plus 3 weeks	No
Secondary	Incidence of adverse effects.		Duration of antibiotic course plus 3 weeks	Yes
Secondary	Presence of pathogens in fecal samples.		Duration of antibiotic course	No