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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC control group | Placebo Comparator | Patients diagnosed with ulcerative colitis (UC) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. |
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| UC experimental group | Experimental | 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. |
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| CD control group | Placebo Comparator | Patients diagnosed with Crohn's disease (CD) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. |
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| CD experimental group | Experimental | 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. |
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| Colitis control group | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 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℃. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D003092 | Colitis |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| Colitis experimental group | Experimental | 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. |
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| 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. |
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| D007410 |
| Intestinal Diseases |