Specific disease: Mild to moderate active Crohn's disease (involving the ileum and/or colon)Core symptoms/manifestations: recurrent abdominal pain, diarrhea, bloody stools, abdominal discomfort, intestinal mucosal inflammation, dysbiosis of intestinal flora, damage to intestinal mucosal barrier, and decreased quality of life.
Conditions
Interventions
low-dose group:LS-LBP-001 Living Biological Capsule
high-dose group:LS-LBP-001 Living Biological Capsule
Placebo group:low-dose group
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18 to 65 years old (including boundary values), both male and female are acceptable; 2. Patients diagnosed with Crohn's disease through endoscopic examination, imaging evaluation, and/or histopathological examination; 3. When screening, the CD lesions of study participants should involve at least the ileum and/or colon; 4. When screening, the following conditions are met: CDAI > 150 and = 3; 5. If the treatment plan meets any of the following criteria during screening: (1) Those who have not received CD treatment within the previous 3 months of screening; (2) Those who are currently receiving oral mesalazine and receiving stable dose treatment for at least 2 weeks during screening; 6. Research participants voluntarily participate in clinical trials and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Individuals who are known or suspected to be allergic to gut microbiota products (such as Lactobacillus acidophilus, Bifidobacterium bifidum, Bacillus licheniformis, etc.) or any excipients, such as mesalazine; 2. Study participants with active ulcerative colitis (UC), uncertain colitis, unresected adenomatous colon polyps, colonic mucosal dysplasia (low-grade or high-grade dysplasia), or short bowel syndrome; 3. Study participants with one of the following persistent complications: fistula; abscess (abdominal or perianal); symptomatic intestinal stenosis; history of intestinal resection; fulminant colitis; toxic megacolon; any other manifestations that may require intestinal surgery during the enrollment period of the study; study participants who have undergone stoma surgery or have ileostomy pockets; study participants with diseases that may interfere with drug absorption, including but not limited to short bowel syndrome; study participants who have undergone surgical intestinal resection; 4. The study participants had gastrointestinal infections, manifested as positive fecal bacterial culture for aerobic pathogens during screening, positive fecal egg and parasite tests, or positive Clostridium difficile B toxin in feces; 5. The study participants had a history of active tuberculosis or incomplete cure of tuberculosis, or were receiving treatment for latent tuberculosis infection (LTBI); 6. Patients with HIV, syphilis, active hepatitis B and active hepatitis C; 7. Study participants who have developed active malignant tumors, lymphoproliferative diseases, or recurrent malignant tumors or lymphoproliferative diseases within the previous 5 years prior to screening; 8. Study participants with adenomatous colon polyps or colonic mucosal dysplasia (low or high grade) that have not been removed or completely removed; 9. Study participants who require or receive any parenteral nutrition and/or specialized enteral nutrition; 10. Study participants who have received biologics, immunosuppressants, and fecal microbiota transplantation treatment within the previous 3 months prior to screening; 11. Individuals who have received treatment with glucocorticoids (excluding topical preparations) or systemic antibiotics within the past 2 weeks prior to screening; 12. Individuals who have had or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with test results (such as known severe bleeding tendency, etc.); 13. Individuals with venous catheters, central venous access, vascular implantation devices, heart valves, or other implants that can form biofilms prior to screening; 14. Individuals who have undergone surgery within the 28 days prior to screening, or who plan to undergo surgery during the trial period; 15. Individuals who have used any clinical trial drugs or enrolled in any drug/medical device clinical trials within the previous month prior to screening; 16. Pregnancy or planned pregnancy or lactation period; 17. Individuals who have smoked more than 10 cigarettes per day within the past 3 months prior to taking the study drug for the first time; 18. Alcoholics or frequent drinkers within the first 6 months of taking the study drug, who consume more than 14 units of alcohol per week (1 unit ˜ 200 mL of beer with an alcohol conte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's Disease Activity Index (CDAI) response rate;SES-CD decline rate compared to baseline; | — |
Countries
China
Contacts
Public ContactXiaoyan Wang
The Third Xiangya Hospital Central South University
Outcome results
None listed