Probiotic 6600 as an add-on treatment for ulcerative colitis, Crohn's disease, and colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis

This trial will test whether adding Probiotic 6600 to usual care helps adults with ulcerative colitis, Crohn's disease, or nonspecific colitis reach clinical remission over 24 weeks.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07047339 on ClinicalTrials.gov

What this trial studies

The trial randomized adults with ulcerative colitis, Crohn's disease, or colitis 1:1 to receive Probiotic 6600 capsules or matching placebo in a double-blind design, with a 1-week screening period, 24 weeks of treatment, a one-day exit exam, and a 4-week safety follow-up. An initial phase enrolled 40 UC, 40 CD, and 40 colitis participants who were assigned equally between active and placebo groups. The primary efficacy outcome was clinical remission at 24 weeks defined by disease-specific scores (SCCAI, modified Mayo, and CDAI thresholds). Safety monitoring and informed consent procedures were included, and participants committed to contraception from consent until 3 months after dosing.

Who should consider this trial

Good fit: Adults aged 18–75 who meet diagnostic criteria for ulcerative colitis (modified Mayo ≥4), Crohn's disease (CDAI ≥220), or colitis (SCCAI ≥3), with complete medical history and willingness to use non-pharmacologic contraception as required, are ideal candidates.

Not a fit: Patients who are pregnant, planning to conceive, outside the 18–75 age range, have major uncontrolled comorbidities, or who do not meet the minimum disease-activity thresholds are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If effective, Probiotic 6600 could increase remission rates and reduce symptoms for adults with UC, CD, or colitis when used alongside standard care.

How similar studies have performed: Some probiotic formulations have shown benefit for ulcerative colitis in prior trials, but results for Crohn's disease and mixed colitis have been inconsistent, so this approach has partial prior support rather than uniform proof.

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.

Where this trial is running

Shanghai

• Changhai Hospital — Shanghai, China (Recruiting)

Conditions Colitis; IBD; Probiotic Intervention