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NCT07152886Not yet recruitingPhase 4

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
238 (estimated)
First submitted
26 Aug 2025
Start date
31 Oct 2025
Primary completion date
31 Oct 2027
Lead sponsor
The Affiliated Hospital of Qingdao University
NCT number
NCT07152886

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 238
  • From 31 Oct 2025 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment;
  • Participation in other clinical studies within 3 months prior to enrollment;
  • Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery;
  • Underwent ostomy surgery during the operation (including temporary or permanent ostomy).

Other illness

  • Presence of psychiatric disorders or other conditions that prevent cooperation with the intervention;
  • Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;
  • History of inflammatory bowel disease;
  • History of autoimmune diseases;

Other

  • Pregnancy or breastfeeding;

Who the study is looking for

  • Aged 18-70 years;
  • No restriction on gender;
  • Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);
  • ECOG performance status score of 0-2;
  • Signed informed consent

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Affiliated Hospital of Qingdao University
Coordinator of this site? Confirm its status
QingdaoChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.