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Randomized, double-blind, placebo-controlled trial of probiotics combination Clinical research on treatment of colorectal cancer

Randomized, double-blind, placebo-controlled trial of probiotics combination Clinical research on treatment of colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051543
Enrollment
Unknown
Registered
2021-09-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Colorectal cancer

Interventions

Colorectal cancer control group:no
Colorectal cancer probiotics group:No

Sponsors

Inner Mongolia People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients with colorectal cancer confirmed by histology; 3. KPS score >= 60 points; 4. The expected survival period is at least 3 months and can be followed up; 5. No serious digestive system diseases; 6. Those who have no history of serious heart, liver, kidney and other important organs, blood and endocrine system; 7. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first treatment and commit to use at least one acceptable contraceptive measure (i.e. use of IUDs, spermicide-containing barrier methods, condoms, any form of hormonal contraceptives, or abstinence); 8. Voluntarily participate in this study and sign the informed consent form, and be able to understand and comply with the various requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Those who take probiotics or dairy products containing probiotics for a long time and regularly; 2. Those who cannot cooperate with the collection of stool specimens; 3. Previous major gastrointestinal surgery and major gastrointestinal diseases (such as subtotal gastrectomy, colorectal cancer, gastroenterostomy, active gastrointestinal bleeding, severe absorption dysfunction, etc.); 4. Difficulty swallowing; 5. Suffering from other malignant tumors in the past 5 years and has not been effectively controlled; 6. Active hepatitis B, hepatitis C, HIV(+) and confirmed syphilis subjects; 7. Those who have undergone major surgery within 4 weeks before enrollment; those who have undergone bone marrow biopsy, open biopsy, and intracranial biopsy within 7 days before screening; 8. In the 7 days before entering the group, meet any one of the following laboratory test results: (1) Blood routine: absolute number of neutrophils 1.5xULN (total bilirubin>3xULN in liver metastases or Gilberts syndrome), ALT>2.5xULN, AST>2.5xULN (ALT or / ULN in liver metastases) and AST > 5xULN); (3) Renal function: serum creatinine>1.5xULN and creatinine clearance rate1.5xULN (using CockcroftGault formula to calculate creatinine clearance rate); 9. Suffering from uncontrolled congestive heart failure or hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg after application of antihypertensive drugs), unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled Controlled arrhythmia, seizures that are not controlled by medication; 10. Lactating women, or those planning to become pregnant during the study period; 11. Participated in other clinical trials within 4 weeks; 12. The researcher believes that it is not suitable to participate in this researcher.

Design outcomes

Primary

MeasureTime frame
Intestinal flora metabolomics;Intestinal mucosal barrier;Inflammatory factors;Observation of clinical efficacy indicators;Intestinal flora;

Countries

China

Contacts

Public ContactDong Li

Inner Mongolia People's Hospital

dongli2126@163.com+86 18047192766

Outcome results

None listed

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