General practitioners or gastroenterologists consulting in french private offices
Paris, France
NCT Number: NCT05213910
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 10 days
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)
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time frame: V1(Day0), V2 (Day10) and Day30
Time frame: V1(Day0), V2 (Day10) and Day30
Time frame: V1(Day0), V2 (Day10) and Day30
Time frame: V1(Day0), V2 (Day10) and Day30
Time frame: V1(Day0), V2 (Day10) and Day30
Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Time frame: V2 (Day10)
Evaluated by the Hospital Anxiety and Depression (HAD) scale
Time frame: V2 (Day10)
Calculated with adverse events that may be observed during study period (descriptif results)
Time frame: V2 (Day10)
By counting treatments returned at the V2 visit
Time frame: V2 (Day10)
Evaluated by the investigator (V2) by a questionnaire
Time frame: V2 (Day10) and Day30
Evaluated by the patient (V2 and D30) by a questionnaire
Time frame: Day30
Evaluated by the patient
Time frame: Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30
Metagenomic analysis
PiLeJe
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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