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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520276-10-00 | EU Trial (CTIS) Number |
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This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks.
Secondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg/day in IBS patients in comparison to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day |
|
| Placebo | Placebo Comparator | Placebo, 250mg, 2 capsules/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces Boulardii 250 MG | Drug | Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global Irritable Bowel Syndrome (IBS) symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks. | Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe). | From baseline to day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of Irritable Bowel Syndrome (IBS) patients in comparison to placebo. | Absolute change measured in the Irritable Bowel Syndrome-Quality of Life (IBS-QOL). Minimum score is 0 : poor quality of life. Maximum score : 100 : better quality of life. | From baseline to day 56 and from baseline to day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the proportion of responders in Irritable Bowel Syndrome - with predominant Diarrhea (IBS-D) subgroup, according to the US Food and Drug Administration (FDA) definition. | Proportion of responders in Irritable Bowel Syndrome - with predominant Diarrhea (IBS-D) subgroup (Rome IV criteria at inclusion), according to the FDA definition (≥30% improvement in abdominal pain and a ≥50% reduction in number of days per week with at least one stool that has a consistency of type 6 or 7 on the Bristol Stool Form Scale (BSFS)) at D56 and D84 compared with baseline. The abdominal pain score will be taken from the abdominal pain 11-point numerical rating scale (NRS). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Miclot | Contact | +33 3 44 86 75 84 | +33 | e.miclot@biocodex.fr |
| Hugo-Miguel Dachez De Oliveira | Contact | +33344868228 | +33 | hm.dachezdeoliveira@biocodex.fr |
| Name | Affiliation | Role |
|---|---|---|
| Oana Bernard, DR | Biocodex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Braga | Recruiting | Braga | Portugal |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D053560 | Ichthyosis Bullosa of Siemens |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo 250 mg | Drug | Placebo, 250mg, 2 capsules/day |
|
| To demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global and individual Irritable Bowel Syndrome (IBS) symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), at each time point, in comparison to placebo. | Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe). | From baseline to day 28, day 56 and day 84 |
| To evaluate the proportion of patients who improved ≥ 50 points on Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). | Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe). | At day 28, day 56 and day 84 compared with baseline |
| To evaluate the proportion of responders according to the European Medicines Agency (EMA) definition, after 8 weeks of treatment | Proportion of responders at D56 and D84 according to the EMA definition (patients with a subject's global assessment of efficacy scale (Irritable Bowel Syndrome - Global Improvement Scale, IBS-GIS) of the highest two improvement grades of a 7-point scale (1 : significantly relieved to 7 : significantly worse), and with an abdominal pain score which has improved at least 30% compared to baseline). The abdominal pain score will be taken from the abdominal pain 11-point NRS.(0 : no pain to 10 : worse possible pain) | Day 56 and day 84 |
| Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording adverse events | Safety endpoint : Recording of adverse events and serious adverse events (number of events and number of participants with at least one event) | From baseline to day 84 |
| Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in pulse rate | Safety endpoint : changes in pulse rate (beats per minute) | From baseline to day 84 |
| Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in blood pressure | Safety endpoint : changes in blood pressure (millimeter of mercury (mmHg)) | From baseline to day 84 |
| Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in body weight | Safety endpoint : changes in body weight (kilograms (kg)) | From baseline to day 84 |
| Day 56 and day 84 compared with baseline |
| To explore the proportion of patients who improved ≥ 75 points on Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS). | Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe). | Day 56 compared to baseline |
| To explore the effect of Saccharomyces boulardii CNCM I-745 on each Irritable Bowel Syndrome- Quality of Life (IBS-QOL) subscore in comparison to placebo. | Change from baseline in Irritable Bowel Syndrome- Quality of Life (IBS-QOL)subscores (Dysphoria, Interference with activity, Body Image, Health worry, Food avoidance, Social Reaction, Sexual, and Relationships) at D56 and D84. Minimum score is 0 : poor quality of life. Maximum score : 100 : better quality of life. | Day 56 and day 84 compared to baseline |
| Hospital da Luz | Not yet recruiting | Lisbon | Portugal |
|
| Hospital Universitario Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
|
| Hospital Universitario de León | Recruiting | León | 24008 | Spain |
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| Hospital Universitario Gregorio Marañon & Centro de Salud Pavones | Recruiting | Madrid | 28007 | Spain |
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| Hospital Clínico San Carlos | Not yet recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario La Paz & Hospital Carlos III | Not yet recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario Costa del Sol | Not yet recruiting | Marbella | 29603 | Spain |
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| Hospital Universitario Regional de Málaga | Not yet recruiting | Málaga | 29010 | Spain |
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| Hospital Universitario Central de Asturias & Centro de Salud la Lila | Not yet recruiting | Oviedo | 33011 | Spain |
|
| D004066 | Digestive System Diseases |
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |