Irritable Bowel SyndromePhase 2NCT01545037
Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome
A Phase 2 study testing L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® in people with Irritable Bowel Syndrome, run by Bio-K Plus International Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2012to Jan 2015
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:
- Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
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- Symptom onset must be at least 6 months prior to diagnosis
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand the nature and purpose of the study including potential risks and side effects
- Willing to consent to study participation and to comply with study requirements
- Abdominal pain or discomfort at least 2 days during run-in period associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Completion of all study-related questionnaires
Who cannot join
- Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
- Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
- Any systemic disease that may confound IBS symptoms or compromise subject safety
- Life expectancy < 6 months
- Pregnant female or breastfeeding
- Lactose intolerance
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- Immunodeficient subjects
- Uncontrolled psychiatric disorder
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Eating disorder
- Recent (< 2 weeks) antibiotic administration
- 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
3 sites in 1 country.
United States3 sites
Digestive and Liver Disease Specialists A Medical Group. Inc
Garden Grove, California, 92840
Sprim ALS
San Francisco, California, 94109
Westlake Medical Research
Westlake Village, California, 91631
About this study
Official title: Effect of Lactobacillus Acidophilus CL1285®, L. Casei LBC80R® and L. Rhamnosus CLR2® on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.
Read the detailed description
Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®Dietary supplement
Also called Bio-K+
Each capsule contains 50 billion cfu live of Lactobacillus acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® bacterias. The randomized subjects will consume 2 capsules per day at breakfast.
PlaceboOther
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic capsules | Active comparator | L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks. Receives: Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® |
| Placebo capsules | Placebo comparator | The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Adequate Relief (IBS-AR)
The IBS-AR is a single-question dichotomous (yes/no) tool that asks subjects if they have experienced adequate relief of IBS symptoms over the past week.
Measured: 12 weeks
Secondary outcomes (8)
IBS Global Assessment of Improvement Scale
The IBS-GAI tool asks a single question regarding how recent IBS symptoms have changed since the start of the study. Subjects answer the question on a 1-7 Likert scale with 1 corresponding to "Substantially Worse" and 7 corresponding to "Substantially Improved".
Measured: 12 weeks
IBS Symptom Severity Scale
The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale
Measured: 12 Weeks
IBS Quality of Life
The IBS-QOL is a 34-item questionnaire that assesses the degree to which IBS interfered with quality of life for a subject over the past 30 days. Each item is rated on a 1 to 5 Likert scale, with higher values indicating a lower quality of life.
Measured: 12 Weeks
Abdominal Pain
Abdominal pain severity will be measured on a 0-10 Likert scale.
Measured: 12 Weeks
Stool Consistency
Stool consistency will be rated with the Bristol Stool Chart.
Measured: 12 Weeks
Stool frequency
Throughout the study, subjects will record the number of defecations per day in a diary.
Measured: 12 Weeks
Concomitant medication use
Throughout the study, subjects will record use of any concomitant medication and, if required, the need for rescue medication use each day in a diary.
Measured: 12 Weeks
Adverse Events
Adverse events will be assessed throughout this clinical study. The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 117 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
- Dalia Perelman, MS,RD,CDE, Principal investigator, SPRIM ALSSyam P. Gaddam, MD, Principal investigator, Digestive and Liver Disease Specialists A medical Group Inc.Razming Krumian, DO, Principal investigator, Westlake Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545037
- Sponsor's protocol ID
- 111005-SCN-BIO-IBS-RA
- Status last verified
- Apr 2015
- First submitted
- 1 Mar 2012
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Acidophilus CL1285®, L. Casei LBC80R® and L. Rhamnosus CLR2® on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01545037
- Acronym / sponsor ID
- 111005-SCN-BIO-IBS-RA
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Mar 2012 (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 the safety and effectiveness of Bio-K+ on symptoms of IBS.
Detailed description
Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic capsules | Active comparator | Dietary Supplement: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks. |
| Placebo capsules | Placebo comparator | Other: PlaceboThe placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 years or older
- Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand the nature and purpose of the study including potential risks and side effects
- Willing to consent to study participation and to comply with study requirements
Key exclusion criteria (15 listed)
- Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
- Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
- Any systemic disease that may confound IBS symptoms or compromise subject safety
- Life expectancy < 6 months
- Pregnant female or breastfeeding
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 |
|---|---|---|
| L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®Also: Bio-K+Each capsule contains 50 billion cfu live of Lactobacillus acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® bacterias. The randomized subjects will consume 2 capsules per day at breakfast. | Dietary supplement | Probiotic capsules |
| PlaceboThe placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. | Other | Placebo capsules |
Primary outcome
IBS Adequate Relief (IBS-AR)
Time frame: 12 weeks
The IBS-AR is a single-question dichotomous (yes/no) tool that asks subjects if they have experienced adequate relief of IBS symptoms over the past week.
8 secondary outcomes
IBS Global Assessment of Improvement Scale
Time frame: 12 weeks
IBS Symptom Severity Scale
Time frame: 12 Weeks
IBS Quality of Life
Time frame: 12 Weeks
Abdominal Pain
Time frame: 12 Weeks
Stool Consistency
Time frame: 12 Weeks
Stool frequency
Time frame: 12 Weeks
Concomitant medication use
Time frame: 12 Weeks
Adverse Events
Time frame: 12 Weeks
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 31 Jul 2017.
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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.
Dalia Perelman, MS,RD,CDE principal investigator
SPRIM ALS
Syam P. Gaddam, MD principal investigator
Digestive and Liver Disease Specialists A medical Group Inc.
Razming Krumian, DO principal investigator
Westlake Medical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® in people with Irritable Bowel Syndrome, run by Bio-K Plus International Inc. at 3 sites 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 15 inclusion and 15 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IBS Adequate Relief (IBS-AR) (time frame: 12 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 31 Jul 2017.