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New treatment option for Colorectal Adenoma
Official title The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
ClinicalTrials.gov ID: NCT07167342
What this study is testing
What is Clostridium butyricum capsules, Live?
Clostridium butyricum capsules, Live is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for colorectal adenoma.
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
- 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.
- Phase 4: studies an already-approved treatment
- 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 75
You may be able to join if
- 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...
- Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, Shandong, China
- Weifang, Shandong, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, Shandong, China; Weifang, Shandong, China. 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.