Study of Saccharomyces boulardii CNCM I-745 to treat symptoms in adults with non-constipated Irritable Bowel Syndrome

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What is this study about?

This study focuses on Irritable Bowel Syndrome (IBS), specifically the non-constipated type, which is a disorder affecting the digestive system that can cause stomach pain, bloating, and changes in bowel habits. The study will test a treatment called Saccharomyces boulardii CNCM I-745, which is a type of beneficial yeast, comparing it with a placebo. Another medication called loperamide may be used during the study to help manage symptoms.

The purpose of this research is to determine if Saccharomyces boulardii CNCM I-745 can improve overall IBS symptoms when taken over an 8-week period. The treatment will be given in the form of hard capsules that are taken by mouth. The study will measure how the treatment affects various aspects of the condition, including stomach pain, bloating, and overall quality of life.

During the study, participants will take either the treatment or placebo for 12 weeks. The researchers will monitor any changes in symptoms throughout this period and continue observations for some time after the treatment ends. They will also keep track of any side effects that might occur during the study period. The study is designed so that neither the participants nor the doctors know who is receiving the actual treatment or the placebo until the study is complete.

1 Initial assessment and medication start

Your participation begins with an evaluation of Irritable Bowel Syndrome (IBS) symptoms using a special assessment scale called IBS-SSS

You will receive either Saccharomyces boulardii CNCM I-745 capsules or placebo capsules for oral use

You will be asked to maintain your regular nutrition habits throughout the study period

2 First follow-up (Day 28)

Your IBS symptoms will be evaluated again using the IBS-SSS scale

Your response to the treatment will be assessed

Your vital signs and body weight will be measured

3 Main evaluation (Day 56)

A comprehensive evaluation of your symptoms will be conducted using the IBS-SSS scale

Your quality of life will be assessed using a specific questionnaire

Your response to the treatment will be evaluated, including changes in abdominal pain

Your vital signs and body weight will be checked

4 Final assessment (Day 84)

Final evaluation of your IBS symptoms using the IBS-SSS scale

Final quality of life assessment

Final measurement of vital signs and body weight

Overall evaluation of your response to the treatment

Review of any side effects or health changes experienced during the study

Who Can Join the Study?

  • Age between 18 and 65 years (both men and women can participate)
  • Must have been diagnosed with Irritable Bowel Syndrome (IBS), but not the constipation-predominant type
  • Must have a severity score of 175 or higher on the IBS Symptom Severity Scale (a tool used to measure how severe IBS symptoms are)
  • Must be willing and able to maintain current eating habits throughout the study period
  • Must be able to understand and follow study requirements
  • Must be willing to provide written informed consent (formal agreement to participate)
  • For women who can become pregnant: must agree to use effective birth control methods during the study

Who Cannot Join the Study?

  • Known allergy or hypersensitivity to yeast or any ingredients in the study medication
  • Currently taking antifungal medications (medicines that treat fungal infections)
  • History of inflammatory bowel disease (chronic inflammation of digestive tract) such as Crohn’s disease or ulcerative colitis
  • Current diagnosis of celiac disease (condition where gluten damages the small intestine)
  • History of gastrointestinal surgery in the past 6 months (except for appendectomy or gallbladder removal)
  • Current severe constipation (having less than 3 bowel movements per week)
  • Active gastrointestinal infection or food poisoning in the past 4 weeks
  • Current use of probiotics (beneficial bacteria supplements) within the last 2 weeks
  • Pregnant women or women planning pregnancy during the study period
  • Breastfeeding women
  • Current participation in other clinical trials
  • Severe mental health conditions that could affect study participation
  • Inability to follow study procedures or complete required questionnaires

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Virgen del Rocío University Hospital Sevilla Spain
Hospital Da Luz S.A. Lisbon Portugal
Hospital Universitario De Leon Leon Spain
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Hospital Costa del Sol Marbella Spain
Centro de Salud La Jota Zaragoza Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Recruiting
15.08.2025
Spain Spain
Recruiting
15.08.2025

Trial locations

Saccharomyces boulardii CNCM I-745 is a beneficial yeast that is used as a probiotic medication. It helps manage symptoms of Irritable Bowel Syndrome (IBS) in adults who do not have constipation. This probiotic works by supporting gut health and may help reduce various digestive symptoms associated with IBS, such as abdominal discomfort, bloating, and irregular bowel movements. The medication is being studied to evaluate how well it improves overall IBS symptoms compared to a placebo.

Irritable Bowel Syndrome (IBS) – A chronic gastrointestinal disorder that affects the large intestine. IBS involves changes in the patterns of bowel movements and causes recurring abdominal discomfort. The non-constipated type is characterized by loose stools, diarrhea, bloating, and abdominal pain or cramping. Symptoms often come and go in periods of flare-ups and remissions. The condition typically involves heightened sensitivity of the digestive system to various triggers, including certain foods, stress, or hormonal changes.

Trial ID:
2024-520276-10-00
Protocol code:
BoWell – Sb252
Trial Phase:
Therapeutic confirmatory (Phase III)

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