Diarrhea-predominant Irritable Bowel SyndromePhase 3NCT01358708
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
A Phase 3 study testing LACTEOL® 340 mg in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Forest Laboratories at 8 sites in 2 countries.
Trial summary
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- LACTEOL® 340 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2010to Sep 2011
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS-D diagnosis using the Rome III questionnaire
- IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400
- Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)
- Stable diet
- Mental and legal ability to sign informed consent
Who cannot join
- Diagnosis of Inflammatory Bowel Disease (IBD)
- Chronic use of systemic steroids
- Diagnosis of autoimmune Diseases or Disorders
- Invasive abdominal surgery
- Use of antibiotics prior to screening
- Allergy to active substance or any other ingredient in LACTEOL® 340 mg
Show all 9Show fewer
- Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
- Diagnosis of exocrine pancreatic insufficiency
- Use of any experimental drug within the 30 days prior to screening
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France5 sites
Study site
Bordeaux
Study site
Colombes
Study site
Marseille
Study site
Nice
Study site
Rouen
About this study
Official title: Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Read the detailed description
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.
Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.
Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.
Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.
Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.
- Being tested
- LACTEOL® 340 mg, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACTEOL® 340 mgDrug
LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
PLACEBODrug
Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
| Study group | Role | What they receive |
|---|---|---|
| LACTEOL® 340 mg | Experimental | Not described Receives: Drug: LACTEOL® 340 mg |
| PLACEBO | Placebo comparator | Not described Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
Measured: Weekly Assessment (every 7 days)
Secondary outcomes (7)
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
Measured: Weekly Assessment (every 7 days)
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).
Measured: Weekly assessment (every 7 days)
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.
Measured: Daily assessment
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase
The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).
Measured: At Screening and End of Double-Blind Treatment Phase
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).
Measured: Weekly assessment (every 7 days)
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.
Measured: Daily assessment
Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study
Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Administrative reasons
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.
- Other trials for Diarrhea-predominant 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan T Shaw, PhD, Study director, Axcan Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358708
- Sponsor's protocol ID
- MA-LA-IBS09-01
- Status last verified
- Feb 2017
- First submitted
- 16 May 2010
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01358708
- Acronym / sponsor ID
- MA-LA-IBS09-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Detailed description
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.
Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.
Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.
Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.
Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LACTEOL® 340 mg | Experimental | Drug: LACTEOL® 340 mg |
| PLACEBO | Placebo comparator | Drug: PLACEBO |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IBS-D diagnosis using the Rome III questionnaire
- IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400
- Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)
- Stable diet
- Mental and legal ability to sign informed consent
Key exclusion criteria (9 listed)
- Diagnosis of Inflammatory Bowel Disease (IBD)
- Chronic use of systemic steroids
- Diagnosis of autoimmune Diseases or Disorders
- Invasive abdominal surgery
- Use of antibiotics prior to screening
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 |
|---|---|---|
| LACTEOL® 340 mgLACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. | Drug | LACTEOL® 340 mg |
| PLACEBOMatched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. | Drug | PLACEBO |
Primary outcome
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Time frame: Weekly Assessment (every 7 days)
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
7 secondary outcomes
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)
Time frame: Weekly Assessment (every 7 days)
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
Time frame: Weekly assessment (every 7 days)
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
Time frame: Daily assessment
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase
Time frame: At Screening and End of Double-Blind Treatment Phase
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
Time frame: Weekly assessment (every 7 days)
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
Time frame: Daily assessment
Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ivan T Shaw, PhD study director
Axcan Pharma Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LACTEOL® 340 mg in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Forest Laboratories at 8 sites in 2 countries.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2013). 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?
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) (time frame: Weekly Assessment (every 7 days)). 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 21 Mar 2017.