Actively Recruiting
Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
Led by Changhai Hospital · Updated on 2025-07-02
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \>1; CDAI score ≤2 and no single subscore \>1) were used as the primary efficacy index.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ulcerative colitis meeting Chinese clinical guidelines with a modified Mayo score of 4 or higher
- Diagnosed with Crohn's disease meeting Chinese clinical guidelines with a CDAI score of 220 or lower
- Diagnosed with colitis with a modified SCCAI score of 3 or higher
- Aged between 18 and 75 years (both inclusive), any gender
- Have a complete medical history
- Commit to using non-drug contraception and avoid planning children or sperm/egg donation from consent until 3 months after last dose
- Understand the trial details, possible side effects, and voluntarily agree to participate and sign consent
You will not qualify if you...
- Taken prebiotics or probiotics in the past 2 weeks or allergic to the treatment capsules
- Have short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active digestive tract fistula, severe intestinal narrowing causing blockage symptoms, suspected intestinal obstruction, or total colectomy
- Have other autoimmune diseases, blood disorders, tumors, acute infections, severe liver or kidney failure, neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment, AIDS, or mental disorders
- History of psychoactive substance abuse
- History of drug or substance dependence, or heavy alcohol use recently or during the trial
- Pregnant, breastfeeding, or planning pregnancy within 6 months
- Have nervous system diseases such as Alzheimer's, stroke, or Parkinson's
- Participated in other clinical trials within the last 6 months
- Have incomplete medical records including demographic or diagnostic information
- Considered ineligible by investigators for other reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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