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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


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
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