IBD (general)Recruiting
Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
Phase 2 / Phase 3 · Testing Probiotics 6600 · 1 site · Changhai Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Probiotics 6600 (a drug) as a possible treatment. Condition(s) listed: Colitis, IBD (Inflammatory Bowel Disease) and Probiotic Intervention.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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;
- 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;
- Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.
Plus 4 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-07-01 (planned).
- Main results expected around 2026-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Clinical remission rate (To evaluate the effect of taking probiotic 6600 capsules in addition to usual care for 24 weeks on improving the rate…)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional |
| Conditions | Colitis; IBD (Inflammatory Bowel Disease); Probiotic Intervention |
| Lead sponsor | Changhai Hospital |
| Enrollment | 120 (estimated) |
| Start date | 2025-07-01 |
| Primary completion (est.) | 2026-07-01 |
| First posted | 2025-07-02 |
| Last updated | 2025-07-02 |
| Official title | A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis |
| ClinicalTrials.gov ID | NCT07047339 |
Interventions
- Probiotics 6600 (Drug)
As the core commensal bacteria of human body, probiotic 6600 has a unique ability to synthesize adhesins and exopolysaccharides. The intestinal protective effect is mediated by the following mechanisms: (1) regulation of Treg/Th17 balance by producing short-chain fatty acids (SCFAs); (2) activation of TLR2/MyD88 pathway inhibits NF-κB inflammatory cascade; (3) Upregulation of zonula occludens-1 en… - Placebo (Drug)
The placebo capsules were also enteric-coated capsules, and were taken orally twice a day (morning and evening after meals), one capsule each time, with warm water.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital | Shanghai | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.