Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis

Launched by CHANGHAI HOSPITAL · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a probiotic called Probiotic 6600 can help improve symptoms and safety in people with colitis, a type of inflammatory bowel disease (IBD) that includes conditions like ulcerative colitis and Crohn’s disease. The goal is to see if taking this probiotic, alongside regular treatment, can help bring the disease under control better than a placebo (a pill without active medicine) over 24 weeks.

If you are between 18 and 75 years old and have been diagnosed with ulcerative colitis, Crohn’s disease, or colitis based on specific medical guidelines, you might be eligible to join. The study requires participants to have certain scores indicating active disease and to agree to avoid pregnancy and certain medications during the trial. Participants will be randomly assigned to take either the probiotic or a placebo without knowing which one they receive, and their health will be monitored throughout the study, including regular check-ups and a follow-up period after treatment. The study is currently recruiting, and people with serious other health conditions or recent use of probiotics may not qualify. This trial offers a chance to contribute to research that could lead to better treatment options for colitis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)", and modified Mayo score ≥4 points;
• • 2. Crohn's disease (CD) : met the clinical diagnostic criteria of CD "Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)", and CDAI score ≥220;
• • 3. Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.
• • 4. The age of signing the informed consent form was from 18 to 75 years old (including the cut-off value, male and female were not limited);
• • 5. Complete medical history;
• • 6. From the time of informed consent until 3 months after the last dose of dose, the participant committed to not having any plans to have children or to have any plans to donate sperm or eggs, and to voluntarily use non-pharmacologic contraception;
• • 7. Fully understand the content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent.
• Exclusion Criteria:
• • 1. Taking prebiotics or probiotics in the past 2 weeks or allergic to intervention preparations;
• • 2. Short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active fistula of digestive tract, severe intestinal stenosis with obstructive symptoms, suspected intestinal obstruction, total colectomy;
• • 3. Other autoimmune diseases, hematological diseases, tumors, acute infections, severe hepatic and renal insufficiency (ALT\>2 times the upper limit of normal), severe diseases such as neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment (serum creatinine \> 2mg/dL or 177mmol/L), AIDS And mental disorders;
• • 4. History of psychoactive substance abuse;
• • 5. A history of drug or other dependent substance abuse, or heavy alcohol consumption in the last 2 weeks (i.e. 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL of beer or 25mL of 40% spirits or 150mL of wine); Heavy drinkers during the trial;
• • 6. Pregnant or breastfeeding women, or planning to become pregnant in the next 6 months;
• • 7. Nervous system diseases such as Alzheimer's disease, stroke, Parkinson's disease;
• • 8. Participated in other clinical trials within the past 6 months;
• • 9. Incomplete medical record information (including gender, age, diagnostic information, colonoscopy results, pathological diagnosis results and other demographic data, etc.);
• • 10. Other investigators deemed ineligible for enrollment.