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New treatment option for IBS (Irritable Bowel Syndrome)
Official title Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT07168434
What this study is testing
What is Saccharomyces Boulardii 250 MG?
Saccharomyces Boulardii 250 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ibs (irritable bowel syndrome).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female aged ≥ 18 and ≤ 65 years.
- Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.
- IBS-SSS total score ≥ 175 at inclusion.
- Able and willing to maintain their nutrition habits throughout the study participation.
- Able to understand and willing to comply with study requirements and to provide written informed consent.
You likely can't join if
- Diagnosis of IBS-C according to Rome IV criteria.
- Patient with more than 5 bowel movements per day on average during the screening period, according to the patient's diary (BSFS).
- Severe illness(es) or medical condition(s), including gastrointestinal pathologies (other than IBS): gastrointestinal ulcers, coeliac disease...
- History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to...
- Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).
- Fecal transplant within 6 months prior to screening.
See the full eligibility criteria
- Male or female aged ≥ 18 and ≤ 65 years.
- Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.
- IBS-SSS total score ≥ 175 at inclusion.
- Able and willing to maintain their nutrition habits throughout the study participation.
- Able to understand and willing to comply with study requirements and to provide written informed consent.
- For women of childbearing potential: willing to use one or more acceptable birth control method throughout the study participation.
- Diagnosis of IBS-C according to Rome IV criteria.
- Patient with more than 5 bowel movements per day on average during the screening period, according to the patient's diary (BSFS).
- Severe illness(es) or medical condition(s), including gastrointestinal pathologies (other than IBS): gastrointestinal ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, acute or chronic diarrhea...
- History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion).
- Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).
- Fecal transplant within 6 months prior to screening.
- Use of products marketed as prebiotics, probiotics or synbiotics within 2 weeks prior to screening. These products, with the exception of the investigational product, will not be allowed during the trial. Regular cheese...
- Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study.
- Laxatives, antibloating agents, antidiarrheal medication, antispasmodics, within 2 weeks prior to screening. These treatments are not allowed during the study, except loperamide which can be used as rescue medication.
- Daily or regular non-steroidal anti-inflammatory drugs (NSAIDS) at doses above cardiovascular prophylaxis (low dose aspirin) are not allowed within 2 weeks prior to screening and throughout the study participation.
- Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study.
- Treatment with two or more antidepressant/anxiolytic/antipsychotic within 3 months prior to study entry or during the trial. Treatment with a single antidepressant or anxiolytic or antipsychotic agent before and during...
- Treatment with anticholinergics for overactive bladder such as solifenacin, darifenacin, oxybutynin, tolterodine, fesoterodin, propiverin, trospium chloride, or mirabegron, within 1 week prior to screening. These...
- Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components.
- Patients having a central venous catheter, critically ill patients, and immunocompromised patients.
- Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
- Excessive alcohol consumption (\>7 units/week) and/or drug abuse.
- Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation.
- Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator.
- Participant at risk of pregnancy, pregnant or breastfeeding female.
- Participant under guardianship or curatorship.
- Participant under the protection of the Court or deprived of liberty.
- Participant participating in another treatment clinical trial which could interfere with the trial's results or impact the other trial's results; or within 5 half-lives of the study investigational treatment, whichever...
- Participant whose current state of health does not allow him/her to give consent.
The study team makes the final eligibility decision.
Where it's taking place
- Braga, Portugal
- Lisbon, Portugal
- Barcelona, Spain
- León, Spain
- Madrid, Spain
- Marbella, Spain
- Málaga, Spain
- Oviedo, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Braga, Portugal; Lisbon, Portugal; Barcelona, Spain; León, Spain; Madrid, Spain; Marbella, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.