Antibiotic-Associated DiarrheaPhase 3NCT00958308
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
A Phase 3 study testing BIO-K+ CL-1285® in people with Antibiotic-Associated Diarrhea and Clostridium Difficile-Associated Diarrhea, run by Bio-K Plus International Inc..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
- What is being tested?
- BIO-K+ CL-1285®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
- Expected to remain hospitalized for a minimum of 5 days
- Patients who have received less than 36 hours of antibiotic therapy
- Negative pregnancy test at screening
- Obtained his/her informed consent after verbal and written information
- Patients having a telephone available (mobile, work, home)
- Patients having a fridge at home
Who cannot join
- Pregnant or breastfeeding women
- Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
- Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
- Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
- Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
- A previous documented C. Difficile infection < 3 months prior to study initiation ;
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- Ostomized patients, parenteral nutrition users
- Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
- Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
- Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
- Patients with concomitant participation in another clinical trial;
- Patients who are not likely to comply with study requirements
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
- Being tested
- BIO-K+ CL-1285®, Placebo
- Keywords
- Probiotic, Antibiotic-Associated Diarrhea (AAD) Prevention, Clostridium Difficile-Associated Diarrhea (CDAD)Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-K+ CL-1285®Other
A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
PlaceboOther
Placebo is devoid of microorganisms.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. Receives: Other: Placebo |
| BIO-K+ CL-1285 | Active comparator | Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. Receives: Other: BIO-K+ CL-1285® |
| BIO-K+ CL-1285® & placebo | Other | One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. Receives: Other: BIO-K+ CL-1285®; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.
Measured: Up to 40 days
Secondary outcomes (4)
Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.
Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.
Measured: Up to 40 days
Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.
If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.
Measured: Up to 40 days
Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.
Adverse events were reported by patients in the three study groups.
Measured: Up to 40 days
Frequencies of Other Gastrointestinal Symptoms.
Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-K Plus International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Gao XingWang, MD, Principal investigator, Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958308
- Sponsor's protocol ID
- 07-SC-9-BIK-01
- Other IDs
- CL 1285-AAD-CH01
- Status last verified
- Mar 2012
- First submitted
- 12 Aug 2009
- Last updated
- 13 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.
PubMed 20145608
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
- ClinicalTrials.gov ID
- NCT00958308
- Acronym / sponsor ID
- 07-SC-9-BIK-01
- Keywords
- Probiotic, Antibiotic-Associated Diarrhea (AAD) Prevention, Clostridium Difficile-Associated Diarrhea (CDAD)Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 2 Mar 2012
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 the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboTwo capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| BIO-K+ CL-1285 | Active comparator | Other: BIO-K+ CL-1285®Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| BIO-K+ CL-1285® & placebo | Other | Other: BIO-K+ CL-1285®, Other: PlaceboOne probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
- Expected to remain hospitalized for a minimum of 5 days
- Patients who have received less than 36 hours of antibiotic therapy
- Negative pregnancy test at screening
- Obtained his/her informed consent after verbal and written information
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women
- Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
- Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
- Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
- Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
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 |
|---|---|---|
| BIO-K+ CL-1285®A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose. | Other | BIO-K+ CL-1285, BIO-K+ CL-1285® & placebo |
| PlaceboPlacebo is devoid of microorganisms. | Other | BIO-K+ CL-1285® & placebo, Placebo |
Primary outcome
To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
Time frame: Up to 40 days
Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.
4 secondary outcomes
Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.
Time frame: Up to 40 days
Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.
Time frame: Up to 40 days
Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.
Time frame: Up to 40 days
Frequencies of Other Gastrointestinal Symptoms.
Time frame: Up to 40 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20145608Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.
- Dose-response probiotic study for AAD and CDADLink provided by the sponsor.
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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.
Gao XingWang, MD principal investigator
Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BIO-K+ CL-1285® in people with Antibiotic-Associated Diarrhea and Clostridium Difficile-Associated Diarrhea, run by Bio-K Plus International Inc..
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 7 inclusion and 12 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. (time frame: Up to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00958308, which also lists 1 linked publication.
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 13 Mar 2012.