A Phase 2/3 interventional study of Probiotics 6600 and Placebo in Colitis, IBD (Inflammatory Bowel Disease) and Probiotic Intervention, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Changhai Hospital · Phase 2/3, Interventional, and Treatment
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.
127 studies on the registry are indexed under Colitis; 31 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 91 interventional studies indexed under Colitis.
Browse Colitis studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with ulcerative colitis (UC) were given one tablet of placebo twice daily (morning and evening after meals) with warm water.
Drug: Placebo
Patients diagnosed with ulcerative colitis (UC) were given probiotics 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water.
Drug: Probiotics 6600
Patients diagnosed with Crohn's disease (CD) were given one tablet of placebo twice daily (morning and evening after meals) with warm water.
Drug: Placebo
Patients diagnosed with Crohn's disease (CD) were given probiotics 6600 orally twice a day (morning and evening after meals), one tablet each time, with warm water.
Drug: Probiotics 6600
Patients diagnosed with colitis (non-ulcerative colitis or Crohn's disease) were given one tablet of placebo twice daily (morning and evening after meals) with warm water.
Drug: Placebo
For patients diagnosed with colitis (non-ulcerative colitis or Crohn's disease), take probiotic 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water.
Drug: Probiotics 6600
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 enhances intestinal barrier function. Notably, this strain specifically metabolized arabinoxylan to produce the anti-inflammatory metabolite indole lactate, which has important therapeutic value in the colitis microenvironment. Probiotic 6600 capsules are enteric capsules (containing probiotic 6600 10\^11 CFU/ capsule), taken orally twice a day (after meals in the morning and evening), one capsule each time, and taken with warm water. The drug was stored at 2-8℃.
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.
Clinical remission rate
To evaluate the efficacy of probiotic 6600 capsule in the adjuvant treatment of patients with colitis. We assessed the rate of clinical remission (UC group: Mayo score ≤2 and no single subscore \>1; CD group: CDAI score \< 150; Colitis group: SCCAI score ≤2 and no single subscore \>1).
Time frame: To evaluate the effect of taking probiotic 6600 capsules in addition to usual care for 24 weeks on improving the rate of clinical remission compared with the control group.
Plan to share: Undecided
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