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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Changhai Hospital
  Shanghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.