Irritable Bowel Syndrome and Lactibiane Tolerance

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529359
• Other study ID #: PiLeJe-LactiTol-0210
• Status: Completed
• Phase: N/A
• Start date: March 24, 2010
• Est. completion date: February 11, 2013

Study information

• Verified date: April 2021
• Source: Larena SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: February 11, 2013
• Est. primary completion date: February 4, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Lactibiane Tolerance
Probiotics combination 2 gelules per days during 6 weeks
• Placebo
Placebo 2 gelules per days for 6 weeks

Locations

Country	Name	City	State
France	Chu L'Archet 2	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
PiLeJe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life	Effect of the intervention on transit and abdominal pain	after 6 weeks of complementation
Secondary	Severity of Anxiety/Depression	The level of anxiety/depression will be measured with the HAD scale	after 6 weeks of complementation
Secondary	Impact of the complementation on fatigue	The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)	after 6 weeks of complementation
Secondary	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	after 6 weeks of complementation
Secondary	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	after 6 weeks of complementation
Secondary	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	after 2 weeks of wash-out
Secondary	Quality of life	Effect of the intervention on transit and abdominal pain	after 2 weeks of wash-out
Secondary	severity of the anxiety/depression	The level of anxiety/depression will be measured with the HAD scale	after 2 weeks of wash-out
Secondary	Impact of the complementation on fatigue	The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)	After 2 weeks of wash out
Secondary	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	after 2 weeks of wash out
Secondary	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	after 2 weeks of wash-out