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Saccharomyces boulardii for Gut Health and Constipation Relief After Colonoscopy: A Clinical Study

Effects of Saccharomyces boulardii Sachet on Gut Microbiota and Clinical Efficacy in Chronic Constipation Patients After Colonoscopy: A Single-Center, Prospective, Open-Label, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115597
Enrollment
Unknown
Registered
2025-12-29
Start date
2025-12-29
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

constipation

Interventions

Experimental group:Saccharomyces boulardii Sachet
Control group:Only routine bowel preparation and colonoscopy are performed, with no additional drug intervention.

Sponsors

Yuebei People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for functional gastrointestinal disorders (Rome IV), and has a record of defecation frequency less than 3 times per week in the past three months. 2. Outpatient patients who need to undergo colonoscopy. 3. Aged between 18 and 75 years. 4. Confirmed to have no severe intestinal diseases (e.g., intestinal obstruction, intestinal tumors, etc.). 5. Voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic or local malignant tumors, or those who cannot discontinue immunosuppressants. 2. Patients with digestive system diseases that significantly affect the study: inflammatory bowel disease, infectious gastrointestinal disease, or some patients with intestinal polyps. 3. Patients with abnormal results of routine stool tests. 4. Patients with severe psychological or mental illnesses. 5. Patients with a history of drug abuse or alcohol abuse, or those who have consumed large amounts of alcohol or used antibiotics within the past month. 6. Patients allergic to the study drug. 7. Patients who cannot discontinue drugs, health products, or foods that cause diarrhea or affect intestinal flora during the trial, including: laxative Western medicines or Chinese patent medicines. 8. Patients who have undergone colonoscopy (or bowel preparation) within the past month. 9. Pregnant or lactating women. 10. Patients who are currently participating in other clinical trials, or who have completed other clinical trials for less than 3 months. 11. Patients with severe cardiac, hepatic, or renal insufficiency. 12. Other patients deemed unsuitable for enrollment by the researchers.

Design outcomes

Primary

MeasureTime frame
Clinical effective rate after 14 days of medication: Improvement effect on defecation frequency and stool consistency;

Secondary

MeasureTime frame
gut microbiota sequencing;fecal calprotectin and serum zonulin;

Countries

China

Contacts

Public ContactChen Bin

Yuebei People’s Hospital

Ybcb333@163.com+86 751 691 3277

Outcome results

None listed

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