Irritable Bowel Syndrome and Lactibiane Tolerance
Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
1 other identifier
interventional
123
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2010
CompletedFirst Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2013
CompletedApril 20, 2021
April 1, 2021
2.9 years
October 10, 2011
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
After 6 weeks of complementation
Secondary Outcomes (11)
Quality of life
after 6 weeks of complementation
Severity of Anxiety/Depression
after 6 weeks of complementation
Impact of the complementation on fatigue
after 6 weeks of complementation
Impact of the intervention on immunological parameters in stools
after 6 weeks of complementation
Impact of the intervention on immunological parameters in blood
after 6 weeks of complementation
- +6 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORProbiotics Excipients
Lactibiane Tolerance
EXPERIMENTALProbiotics combination
Interventions
Probiotics combination 2 gelules per days during 6 weeks
Eligibility Criteria
You may qualify if:
- Irritable bowel syndrome according to the Rome II criteria
- \< Francis Score \< 300
- HAD score inferior or egal to 25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PiLeJelead
Study Sites (1)
Chu L'Archet 2
Nice, Alpes Maritimes, 06200, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piche Thierry, MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2011
First Posted
February 8, 2012
Study Start
March 24, 2010
Primary Completion
February 4, 2013
Study Completion
February 11, 2013
Last Updated
April 20, 2021
Record last verified: 2021-04