Saccharomyces cerevisiae CNCM I-3856
Dietary Supplement2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
NCT Number: NCT03150212
The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
General pratices, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Rome IV:
A) Recurrent abdominal pain, with an average of at least 1 day a week within the last 3 months, and associated with 2 following criteria:
B) Onset of the above symptoms at least 6 months before the diagnostic,
C) More than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2 and less than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 (check during the last 14 days using the stools frequency questionnaire associated to the Bristol Stools Scale "BSS"),
Exclusion criteria
2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
Time frame: Week 5 to Week 8
Total AUC W5-W8 (expressed in a.u./day.week) of abdominal pain/discomfort calculated using the mean daily score rated with Likert scale (ranging from 0 to 7) from week 5 to week 8 (included)
Lesaffre International
Industry
Randomized Double Blind Placebo-controlled Clinical Study : Effect of IBSIUM on the Improvement of Gastro-intestinal Disorders Associated to the Irritable Bowel Syndrome (IBS) With C Phenotype (Predominant-constipation)
Acronym: IBS-GO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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