NCT07167342 The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
| NCT ID | NCT07167342 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Affiliated Hospital of Qingdao University |
| Condition | Colorectal Adenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 294 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 294 participants in total. It began in 2026-05-22 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 75 years * No restriction on sex * Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure * Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically * Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation * Able to take oral medication * Signed informed consent Exclusion Criteria: * Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment * Presence of psychiatric disorders or other conditions preventing compliance with the intervention * Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation * Participation in other clinical trials within 3 months prior to enrollment * History of gastrointestinal surgery (excluding endoscopic procedures) * History of inflammatory bowel disease * History of autoimmune diseases * Long-term use of aspirin (≥100 mg/day for over 3 months) or calcium supplements (≥1200 mg/day for over 3 months) * Pregnancy or breastfeeding * Previous treatment for colorectal adenomas (including endoscopic or surgical resection) * Familial adenomatous polyposis (FAP)
Contact & Investigator
yanbing Zhou
STUDY CHAIR
The Affiliated Hospital of Qingdao University
Frequently Asked Questions
Who can join the NCT07167342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Adenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07167342 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07167342 currently recruiting?
Yes, NCT07167342 is actively recruiting participants. Contact the research team at docliu163@163.com for enrollment information.
Where is the NCT07167342 trial being conducted?
This trial is being conducted at Qingdao, China, Weifang, China.
Who is sponsoring the NCT07167342 clinical trial?
NCT07167342 is sponsored by The Affiliated Hospital of Qingdao University. The principal investigator is yanbing Zhou at The Affiliated Hospital of Qingdao University. The trial plans to enroll 294 participants.