Changhai Hospital
Shanghai, China
Location status: Recruiting
NCT Number: NCT07047339
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Changhai Hospital
Other
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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