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Irritable Bowel Syndrome and Lactibiane Tolerance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Pileje.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pileje
ClinicalTrials.gov Identifier:
NCT01529359
First received: October 10, 2011
Last updated: February 6, 2012
Last verified: February 2012
  Purpose
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).

Condition Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: Lactibiane Tolerance
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

Further study details as provided by Pileje:

Primary Outcome Measures:
  • Severity of bowel symptoms according to the Francis Score [ Time Frame: After 6 weeks of complementation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: after 6 weeks of complementation ] [ Designated as safety issue: No ]
    Effect of the intervention on transit and abdominal pain

  • Severity of Anxiety/Depression [ Time Frame: after 6 weeks of complementation ] [ Designated as safety issue: No ]
    The level of anxiety/depression will be measured with the HAD scale

  • Impact of the complementation on fatigue [ Time Frame: after 6 weeks of complementation ] [ Designated as safety issue: No ]
    The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)

  • Impact of the intervention on immunological parameters in stools [ Time Frame: after 6 weeks of complementation ] [ Designated as safety issue: No ]
    The effects of the intervention on immunological parameters in stools will be evaluated via the levels of beta-defensine 2 and sérine protease activities

  • Impact of the intervention on immunological parameters in blood [ Time Frame: after 6 weeks of complementation ] [ Designated as safety issue: No ]
    The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines

  • Severity of bowel symptoms according to the Francis Score [ Time Frame: after 2 weeks of wash-out ] [ Designated as safety issue: No ]
    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

  • Quality of life [ Time Frame: after 2 weeks of wash-out ] [ Designated as safety issue: No ]
    Effect of the intervention on transit and abdominal pain

  • severity of the anxiety/depression [ Time Frame: after 2 weeks of wash-out ] [ Designated as safety issue: No ]
    The level of anxiety/depression will be measured with the HAD scale

  • Impact of the complementation on fatigue [ Time Frame: After 2 weeks of wash out ] [ Designated as safety issue: No ]
    The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)

  • Impact of the intervention on immunological parameters in stools [ Time Frame: after 2 weeks of wash out ] [ Designated as safety issue: No ]
    The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities

  • Impact of the intervention on immunological parameters in blood [ Time Frame: after 2 weeks of wash-out ] [ Designated as safety issue: No ]
    The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines


Estimated Enrollment: 94
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Probiotics Excipients
Dietary Supplement: Placebo
Placebo 2 gelules per days for 6 weeks
Experimental: Lactibiane Tolerance
Probiotics combination
Dietary Supplement: Lactibiane Tolerance
Probiotics combination 2 gelules per days during 6 weeks
Other Name: Probiotic

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Irritable bowel syndrome according to the Rome II criteria
  • 150< Francis Score < 300
  • HAD score inferior or egal to 25

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529359

Locations
France
Chu L'Archet 2
Nice, Alpes Maritimes, France, 06200
Sponsors and Collaborators
Pileje
Investigators
Principal Investigator: Piche Thierry, MD
  More Information

Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT01529359     History of Changes
Other Study ID Numbers: PiLeJe-LactiTol-0210 
Study First Received: October 10, 2011
Last Updated: February 6, 2012
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pileje:
Irritable Bowel Syndrome
Probiotics

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 08, 2016