NCT00641199

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

March 18, 2008

Last Update Submit

January 14, 2010

Conditions

Antibiotic-Associated Diarrhea

Keywords

Antibiotic-associated diarrheaProbioticQuality of lifeAntibiotics

Outcome Measures

Primary Outcomes (1)

  • Incidence of patients experiencing diarrhea

    Duration of antibiotic course plus 3 weeks

Secondary Outcomes (5)

  • Duration of diarrhea

    Duration of antibiotic course plus 3 weeks

  • Quality of life.

    Duration of antibiotic course plus 3 weeks

  • Gastrointestinal Symptom Rating Scale score.

    Duration of antibiotic course plus 3 weeks

  • Incidence of adverse effects.

    Duration of antibiotic course plus 3 weeks

  • Presence of pathogens in fecal samples.

    Duration of antibiotic course

Study Arms (2)

1

ACTIVE COMPARATOR

Jarrow-Dophilus EPS

Other: Jarro-Dophilus EPS probiotics

2

PLACEBO COMPARATOR

Placebo

Other: Jarro-Dophilus EPS probiotics

Interventions

Jarro-Dophilus EPS probioticsOTHER

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

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5C9, Canada

Location

Study Officials

  • Yvonne M Shevchuk, B.S.P., Pharm D.

    College of Pharmacy and Nutrition, University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

CA(1)