Efficacy and Safety of Saccharomyces boulardii Plus Pinaverium Bromide for Diarrhea-Predominant Irritable Bowel Syndrome: A Multicenter, Randomized, Open-Label Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500105272

Enrollment

Unknown

Registered

2025-07-01

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea-predominant irritable bowel syndrome (IBS-D)

Interventions

ontrol Group: Pinaverium bromide (Dicetel) monotherapy:Pinaverium bromide

Experimental Group: Saccharomyces boulardii combined with pinaverium bromide (Dicetel) Key Features of the Translation::Saccharomyces boulardii combined with pinaverium bromide (Dicetel)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–60 years; 2.Diagnosed with IBS-D per Rome IV criteria, with a baseline IBS-SSS score =75; 3.Normal colonoscopy findings within the past 2 years, or clinically insignificant abnormalities as assessed by the investigator; 4.Ability to complete electronic questionnaires; 5.Active diarrhea symptoms, with normal or clinically insignificant liver/kidney/thyroid function test results within the past year; 6.Willingness to undergo treatment and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy to any drug in the treatment regimen; 2.History of abdominal or pelvic surgery; 3.Organic intestinal diseases or other subtypes of IBS (e.g., IBS-C, IBS-M); 4.Severe impairment of major organs (respiratory, cardiac, hepatic, or renal dysfunction); 5.Thyroid dysfunction; 6.Organic biliary or pancreatic diseases; 7.Hyperchlorhydria (excessive gastric acid secretion); 8.Celiac disease or lactose intolerance; 9.Pregnant or breastfeeding women; 10.Alcohol abuse, drug addiction, or severe neurocognitive disorders; 11.Use of probiotics or medications affecting intestinal function within the past month; 12.Participation in another clinical trial within the past 3 months; 13.Other conditions deemed ineligible by the investigator.

Design outcomes

Primary

Measure	Time frame
IBS-SSS;	—

Secondary

Measure	Time frame
Bristol Stool Form Normalization;IBS-QOL;	—

Countries

China

Contacts

Public ContactWei-Feng Huang

The First Affiliated Hospital of Xiamen University

hwf0625@163.com+86 181 5090 6129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026