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Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)

Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033953
Enrollment
Unknown
Registered
2020-06-18
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

Ulcerative colitis

Interventions

experimental group 1:Lactobacillus plantarum CCFM8610
experimental group 2:Lactobacillus plantarum N13
experimental group 3:Lactobacillus casei CCFM1059

Sponsors

Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. UC patients aged 18-65 years, both male and female; 2. Patients who have good compliance and are able to comply with the requirements of the clinical trial, and promise to cooperate with the study during the whole experimental period; 3. Patients who meet UC diagnostic criteria and are diagnosed with UC. UC is in the active stage, the degree is light or moderate, the ucdai score is between 3-9; 4. Patients who fill in the written informed consent and the quality of life certificate of inflammatory bowel disease.

Exclusion criteria

Exclusion criteria: 1. Patients with serious liver, kidney, heart, respiratory system diseases, endocrine diseases, inflammatory diseases and mental diseases diagnosed by the hospital; 2. Patients with gastrointestinal infection and other gastrointestinal diseases diagnosed by the hospital; 3. Patients who have had major abdominal surgery, especially gastrointestinal surgery; 4. Patients with gastrointestinal cancer or IBS; 5. Patients with severe UC symptoms who need operation urgently; 6. Patients who are allergic to mesalazine and whose dosage has changed in the past month (mesalazine is allowed); 7. Patients with other types of immune system diseases, such as rheumatoid arthritis, systemic lupus erythematosus, Graves disease, psoriasis, etc; 8. The current or recent (1 month) or long-term use of antibiotics, the current or recent (3 months) or long-term use of glucocorticoids (such as cortisol), steroids, immunosuppressive drugs or biological targeted drugs; 9. Patients who take probiotics, microecological preparations and dietary supplements in the near future (within one month) or for a long time; 10. Patients with significant changes in their eating habits in the near future (within one month), such as starting to eat a fiber rich diet; 11. Patients who are allergic to the ingredients of experimental probiotic products or lactose intolerant; 12. For women, patients who are pregnant, breastfeeding or wish to be pregnant; 13. Patients who are currently or in the near future (within 3 months) in other clinical studies; 14. Patients who cannot tolerate or accept colonoscopy; 15. Patients who are unwilling or unable to provide written informed consent to participate in the study after the researcher informs the researcher of the purpose, process and possible risks; 16. Patients who do not meet the requirements of the study or who the researchers believe should not participate in the study.

Design outcomes

Primary

MeasureTime frame
C-Reactive Protein;Fecal occult blood;Ulcerative colitis disease activity index;Ulcerative colitis endoscopic index of severity;Inflammatory bowel disease quality of life scale;

Secondary

MeasureTime frame
Serum IL-1ß;Serum IL-6;Serum TNF-a;Serum IFN-?;Serum myeloperoxidase;Serum IL-10;Fecal calprotectin;Fecal microbiota;Fecal short-chain fatty acid;

Countries

China

Contacts

Public ContactQixiao Zhai

Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 15961760920

Outcome results

None listed

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