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Research on the protective mechanism of gastrointestinal inflammation after taking aspirin by Bifidobacterium animalis subsp. lactis Probio-M8

Research on the protective mechanism of gastrointestinal inflammation after taking aspirin by Bifidobacterium animalis subsp. lactis Probio-M8

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105785
Enrollment
Unknown
Registered
2025-07-10
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Coronary heart disease

Interventions

Probiotic group:Take 1 bag of probiotics/day, 1 aspirin enteric tablets/day once a day, and 1 tablet of resuvastatin calcium tablets/day twice a day
Placebo group :Take 1 bag of placebo/day, 1 aspirin enteric tablet/day, and 1 tablet of resuvastatin calcium tablets/day twice a day

Sponsors

People's Hospital of Inner Mongolia Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with clinical diagnosis of coronary heart disease; 2. At the time of informed consent, male or female subjects aged >=18 and <=85 years old; 3. Subjects who have not been treated for coronary heart disease can enter the study; 4. There is a confirmed research partner (defined as a person who can support the subject during the research period and accompany the subject for at least 8 hours a week, and is willing to provide follow-up information about the subject throughout the research process). The research partner needs to provide and sign a separate written informed consent form; in clinical evaluation At the time of assessment, research partners need to accompany and participate in person; 5. Subjects and/or guardians can fully understand the informed consent content of this experiment and voluntarily sign the informed consent form; 6. Gastroenteroscopy shows that there is no obvious abnormality.

Exclusion criteria

Exclusion criteria: 1. During screening or baseline, women who are breastfeeding or pregnant; 2. Patients with cognitive dysfunction; 3. Mental disorders in the past or during the study period, mental symptoms (hallucinations, severe anxiety or depression, etc.) that interfere with the research process according to the fifth edition of the Mental Disorders of the Diagnostic and Statistical Manual (DSM-5) or interfere with the subject's course; 4. Abnormalities found in physical examination, vital signs, laboratory examination, heart/ELECTROEG, etc., and any other clinically significant abnormalities that the researcher believes need further research or treatment, or may interfere with the research procedure or safety; 5. There are malignant tumors (except for basal or squamous cell carcinoma in the skin in place, or local prostate cancer of male subjects); 6. Any other diseases that cannot be stable and controlled or other diseases that the researchers believe may affect the safety of the study (such as heart, respiratory, gastrointestinal, kidney disease, HIV positive, etc.); 7. Serious visual or hearing impairments affect the accurate psychological test of the subjects; 8. Have a history of drug abuse and long-term alcoholism; 9. Have a history of inflammatory bowel disease, intestinal obstruction, intestinal perforation, intestinal bleeding, coeliac disease, irritable bowel syndrome or eosinophilosis, esophagitis, eosinophilic gastroenteritis, Helicobacter pylori infection and other similar diseases; 10. Those who are participating in other clinical studies, or have received intervention measures from other interventional clinical studies within 4 weeks before joining the group; 11. Those who have received drugs that affect this study in the past 1 month, such as antibacterial drugs, microecological preparations, proton pump inhibitors, etc., or have taken other antithrombotic drugs and non-steroidal anti-inflammatory drugs at the same time; 12. Those who are allergic to the drugs required for the experiment;

Design outcomes

Primary

MeasureTime frame
Modified Lanza Score;

Secondary

MeasureTime frame
The degree of carotid artery stenosis;Left ventricular blood ejection fraction;Blood biochemical;Inflammation-related factors;Intestinal microbial metabolic group;Macrogenome sequencing and bioinformatics analysis of intestinal flora;Blood metabolic group indicators;Detection of Helicobacter pylori;Gastrointestinal Symptom Score Quantitative Table (GSRS);

Countries

China

Contacts

Public ContactHou Yu

People's Hospital of Inner Mongolia Autonomous Regionn

rmyyhy1234@163.com+86 181 0471 1002

Outcome results

None listed

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