Antibiotic-Associated DiarrheaNCT00641199
Probiotics for Prevention of Antibiotic-associated Diarrhea
A study testing Jarro-Dophilus EPS probiotics in people with Antibiotic-Associated Diarrhea, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antibiotic-Associated Diarrhea
- What is being tested?
- Jarro-Dophilus EPS probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.
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.
Read the detailed 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.
- Conditions
- Antibiotic-Associated Diarrhea
- Being tested
- Jarro-Dophilus EPS probiotics
- Keywords
- Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarro-Dophilus EPS probioticsOther
Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Jarrow-Dophilus EPS Receives: Other: Jarro-Dophilus EPS probiotics |
| 2 | Placebo comparator | Placebo Receives: Other: Jarro-Dophilus EPS probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients experiencing diarrhea
Measured: Duration of antibiotic course plus 3 weeks
Secondary outcomes (5)
Duration of diarrhea
Measured: Duration of antibiotic course plus 3 weeks
Quality of life.
Measured: Duration of antibiotic course plus 3 weeks
Gastrointestinal Symptom Rating Scale score.
Measured: Duration of antibiotic course plus 3 weeks
Incidence of adverse effects.
Measured: Duration of antibiotic course plus 3 weeks
Presence of pathogens in fecal samples.
Measured: Duration of antibiotic course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-Associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Jarrow Formulas Inc, Institut Rosell
- Investigators
- Yvonne M Shevchuk, B.S.P., Pharm D., Principal investigator, College of Pharmacy and Nutrition, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641199
- Sponsor's protocol ID
- PAAD-07-112
- Other IDs
- 07-112
- Status last verified
- Jan 2010
- First submitted
- 18 Mar 2008
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.
- ClinicalTrials.gov ID
- NCT00641199
- Acronym / sponsor ID
- PAAD-07-112
- Conditions
- Antibiotic-Associated Diarrhea
- Keywords
- Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Jarrow Formulas Inc, Institut Rosell
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Jarro-Dophilus EPS probioticsJarrow-Dophilus EPS |
| 2 | Placebo comparator | Other: Jarro-Dophilus EPS probioticsPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-75 years of age
- Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jarro-Dophilus EPS probioticsJarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule. | Other | 1, 2 |
Primary outcome
Incidence of patients experiencing diarrhea
Time frame: Duration of antibiotic course plus 3 weeks
5 secondary outcomes
Duration of diarrhea
Time frame: Duration of antibiotic course plus 3 weeks
Quality of life.
Time frame: Duration of antibiotic course plus 3 weeks
Gastrointestinal Symptom Rating Scale score.
Time frame: Duration of antibiotic course plus 3 weeks
Incidence of adverse effects.
Time frame: Duration of antibiotic course plus 3 weeks
Presence of pathogens in fecal samples.
Time frame: Duration of antibiotic course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne M Shevchuk, B.S.P., Pharm D. principal investigator
College of Pharmacy and Nutrition, University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jarro-Dophilus EPS probiotics in people with Antibiotic-Associated Diarrhea, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients experiencing diarrhea (time frame: Duration of antibiotic course plus 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.