Irritable Bowel SyndromeNCT01529359
Irritable Bowel Syndrome and Lactibiane Tolerance
A study testing Lactibiane Tolerance in people with Irritable Bowel Syndrome, run by PiLeJe at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactibiane Tolerance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2010to 11 Feb 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Irritable bowel syndrome according to the Rome II criteria
- 150< Francis Score < 300
- HAD score inferior or egal to 25
Who cannot join
- History of hypersensitivity to one of the composant of the product
- Use of probiotics or antibiotics last four weeks
- use of prohibited drugs
- bowel preparation for morphological examination last month
- pregnancy or lactation
- immundepressed or co-existing other serious illness or evolutive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
Read the detailed description
The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
The secondary purposes are to evaluate the effects of the intervention on:
- quality of life
- severity of fatigue, anxiety and depression
- levels of inflammatory markers in blood and tools
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactibiane Tolerance, Placebo
- Keywords
- Irritable Bowel Syndrome, Probiotics
- 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.
Lactibiane ToleranceDietary supplement
Also called Probiotic
Probiotics combination 2 gelules per days during 6 weeks
PlaceboDietary supplement
Placebo 2 gelules per days for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Probiotics Excipients Receives: Dietary Supplement: Placebo |
| Lactibiane Tolerance | Experimental | Probiotics combination Receives: Dietary Supplement: Lactibiane Tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of bowel symptoms according to the Francis Score
The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.
Measured: After 6 weeks of complementation
Secondary outcomes (11)
Quality of life
Effect of the intervention on transit and abdominal pain
Measured: after 6 weeks of complementation
Severity of Anxiety/Depression
The level of anxiety/depression will be measured with the HAD scale
Measured: after 6 weeks of complementation
Impact of the complementation on fatigue
The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)
Measured: after 6 weeks of complementation
Impact of the intervention on immunological parameters in stools
The effects of the intervention on immunological parameters in stools will be evaluated via the levels of beta-defensine 2 and sérine protease activities
Measured: after 6 weeks of complementation
Impact of the intervention on immunological parameters in blood
The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines
Measured: after 6 weeks of complementation
Severity of bowel symptoms according to the Francis Score
The severity of bowel symptoms is evaluated with the Francis Score before 6 weeks of complementation and after 2 weeks of wash-out in placebo and verum groups
Measured: after 2 weeks of wash-out
Quality of life
Effect of the intervention on transit and abdominal pain
Measured: after 2 weeks of wash-out
severity of the anxiety/depression
The level of anxiety/depression will be measured with the HAD scale
Measured: after 2 weeks of wash-out
Impact of the complementation on fatigue
The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)
Measured: After 2 weeks of wash out
Impact of the intervention on immunological parameters in stools
The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities
Measured: after 2 weeks of wash out
Impact of the intervention on immunological parameters in blood
The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines
Measured: after 2 weeks of wash-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study start24 Mar 2010
- Primary completion4 Feb 2013
- Study completion11 Feb 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piche Thierry, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529359
- Sponsor's protocol ID
- PiLeJe-LactiTol-0210
- Status last verified
- Apr 2021
- First submitted
- 10 Oct 2011
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01529359
- Acronym / sponsor ID
- PiLeJe-LactiTol-0210
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2010 (actual)
- Primary completion
- 4 Feb 2013 (actual)
- Study completion
- 11 Feb 2013 (actual)
- First posted
- 8 Feb 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 effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
Detailed description
The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
The secondary purposes are to evaluate the effects of the intervention on:
- quality of life
- severity of fatigue, anxiety and depression
- levels of inflammatory markers in blood and tools
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboProbiotics Excipients |
| Lactibiane Tolerance | Experimental | Dietary Supplement: Lactibiane ToleranceProbiotics combination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Irritable bowel syndrome according to the Rome II criteria
- 150< Francis Score < 300
- HAD score inferior or egal to 25
Key exclusion criteria (6 listed)
- History of hypersensitivity to one of the composant of the product
- Use of probiotics or antibiotics last four weeks
- use of prohibited drugs
- bowel preparation for morphological examination last month
- pregnancy or lactation
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 |
|---|---|---|
| Lactibiane ToleranceAlso: ProbioticProbiotics combination 2 gelules per days during 6 weeks | Dietary supplement | Lactibiane Tolerance |
| PlaceboPlacebo 2 gelules per days for 6 weeks | Dietary supplement | Placebo |
Primary outcome
Severity of bowel symptoms according to the Francis Score
Time frame: After 6 weeks of complementation
The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.
11 secondary outcomes
Quality of life
Time frame: after 6 weeks of complementation
Severity of Anxiety/Depression
Time frame: after 6 weeks of complementation
Impact of the complementation on fatigue
Time frame: after 6 weeks of complementation
Impact of the intervention on immunological parameters in stools
Time frame: after 6 weeks of complementation
Impact of the intervention on immunological parameters in blood
Time frame: after 6 weeks of complementation
Severity of bowel symptoms according to the Francis Score
Time frame: after 2 weeks of wash-out
Quality of life
Time frame: after 2 weeks of wash-out
severity of the anxiety/depression
Time frame: after 2 weeks of wash-out
Impact of the complementation on fatigue
Time frame: After 2 weeks of wash out
Impact of the intervention on immunological parameters in stools
Time frame: after 2 weeks of wash out
Impact of the intervention on immunological parameters in blood
Time frame: after 2 weeks of wash-out
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 20 Apr 2021.
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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.
Piche Thierry, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactibiane Tolerance in people with Irritable Bowel Syndrome, run by PiLeJe at 1 site in France.
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 3 inclusion and 6 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 20 Apr 2021. 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 France. 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?
Severity of bowel symptoms according to the Francis Score (time frame: After 6 weeks of complementation). 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 20 Apr 2021.