Recurrent Clostridium Difficile InfectionPhase 3NCT01202630
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
A Phase 3 study testing Lactobacillus acidophilus CL1285® and Lactobacillus casei in people with Recurrent Clostridium Difficile Infection, run by Bio-K Plus International Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Clostridium Difficile Infection
- What is being tested?
- Lactobacillus acidophilus CL1285® and Lactobacillus casei
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
- Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Understand the nature and purpose of the study including potential risks and side effects
- Willing to comply with the requirements of the study
Who cannot join
- History of 2 or more clostridium difficile infections at any time prior to the current episode
- Presence of severe chronic and/or inflammatory condition
- Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Use of proton pump inhibitors
Show all 12Show fewer
- Pregnant female or breastfeeding
- Eating disorder
- History of alcohol, drug, or medication abuse
- Daily consumption of probiotics, fermented milk, and/or yogurt
- Known allergies to any substance in the study product
- Participation in another study with any investigational product within 3 months of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Parker Jewish Institute
New Hyde Park, New York, 11040
About this study
Official title: A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
- Being tested
- Lactobacillus acidophilus CL1285® and Lactobacillus casei, Placebo
- Keywords
- Clostridium difficile, diarrhea
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus CL1285® and Lactobacillus caseiDietary supplement
Also called BIO-K+ CL 1285
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
PlaceboDietary supplement
2 capsules of placebo (no live cells), consumed once daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | BIO-K+ CL1285 Receives: Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent Clostridium difficile infection
Measured: 60 days
Secondary outcomes (3)
Duration of recurrent diarrhea episodes
Measured: 60 days
Presence of gastrointestinal symptoms
Measured: 60 days
Adverse events
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: The site is unable to recruit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Clostridium Difficile InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
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
- Cornelius J Foley, MD, Principal investigator, Parker Jewish for Health Care and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202630
- Sponsor's protocol ID
- 09-SUS-05-BIK-02
- Status last verified
- Jan 2016
- First submitted
- 14 Sep 2010
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT01202630
- Acronym / sponsor ID
- 09-SUS-05-BIK-02
- Keywords
- Clostridium difficile, diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The site is unable to recruit patients.
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Jun 2010
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 16 Sep 2010 (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 primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
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 |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus caseiBIO-K+ CL1285 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
- Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Understand the nature and purpose of the study including potential risks and side effects
Key exclusion criteria (12 listed)
- History of 2 or more clostridium difficile infections at any time prior to the current episode
- Presence of severe chronic and/or inflammatory condition
- Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
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 |
|---|---|---|
| Lactobacillus acidophilus CL1285® and Lactobacillus caseiAlso: BIO-K+ CL 12852 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days | Dietary supplement | Probiotic |
| Placebo2 capsules of placebo (no live cells), consumed once daily for 60 days | Dietary supplement | Placebo |
Primary outcome
Incidence of recurrent Clostridium difficile infection
Time frame: 60 days
3 secondary outcomes
Duration of recurrent diarrhea episodes
Time frame: 60 days
Presence of gastrointestinal symptoms
Time frame: 60 days
Adverse events
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Background: 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.
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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.
Cornelius J Foley, MD principal investigator
Parker Jewish for Health Care and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus acidophilus CL1285® and Lactobacillus casei in people with Recurrent Clostridium Difficile Infection, run by Bio-K Plus International Inc. at 1 site in United States.
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 6 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: paused, as of the sponsor's last update on 15 Jan 2016. 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 United States. 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.
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?
Results are not available in the source record.
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 recurrent Clostridium difficile infection (time frame: 60 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 NCT01202630, 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 15 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.