The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
189
dosage form: mix of 8 strains containing 1.2x10\^11 CFU frequency, and duration: 2 capsules/day during 10 days
3 stool samples are taken during the study (D0, D10 and D30)
General practitioners or gastroenterologists consulting in french private offices
Paris, France
Evolution of the severity of functional bowel disorders
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time frame: 10 days
Evolution of the severity of functional bowel disorders
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time frame: Between V2 (Day10) and Day30 (20 days)
Description of the symptomatology
\- 10-day average stool consistency according to the Bristol Stool Scale;
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
\- 10-day average daily stool frequency;
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
\- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
\- 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)
Time frame: V1(Day0), V2 (Day10) and Day30
Description of quality of life
Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Time frame: V1(Day0), V2 (Day10) and Day30
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Description of the anxiety-depressive disorders
Evaluated by the Hospital Anxiety and Depression (HAD) scale
Time frame: V2 (Day10)
Safety (tolerance to treatment)
Calculated with adverse events that may be observed during study period (descriptif results)
Time frame: V2 (Day10)
Treatment compliance
By counting treatments returned at the V2 visit
Time frame: V2 (Day10)
Global clinical evaluation
Evaluated by the investigator (V2) by a questionnaire
Time frame: V2 (Day10)
Global clinical evaluation
Evaluated by the patient (V2 and D30) by a questionnaire
Time frame: V2 (Day10) and Day30
Evaluation of the satisfaction concerning the product by a questionnaire
Evaluated by the patient
Time frame: Day30