Shenzhen Hospital of Southern Medical University
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Modified Mayo endoscopic score
研究概览
简要总结
Through a series of studies,the investigators has discovered for the first time that gut microbiota-derived DL-endopeptidase is a core regulator of the NOD2 pathway. This research also reveals a novel etiological mechanism in which deficiency of gut bacterial DL-endopeptidase leads to dysfunctional NOD2 signaling, thereby promoting the pathogenesis of inflammatory bowel disease (IBD).( The findings have been published in Cell Host & Microbe and Nature Communications.) Based on this, the investigators has successfully screened a high DL-endopeptidase-producing active strain, Lactobacillus rhamnosus CALM 607 (abbreviated as LR607), from the traditional probiotic Lactobacillus rhamnosus.(Its unique advantages include: 1) Independent intellectual property rights (patent applied for);2) DL-endopeptidase production and NOD2 regulatory ability 2.7 times higher than that of the conventional strain LGG;3) Preclinical experiments have demonstrated its potential to alleviate intestinal inflammation.) The investigators' Phase I clinical trial (data pending publication) has confirmed that LR607 has good safety and tolerability in healthy volunteers, providing a safety foundation for subsequent clinical studies.
Therefore, the investigators aim to investigate the DL-endopeptidase-producing probiotic LR607 through randomized controlled clinical intervention studies, to evaluate its adverse effects in adjunctive therapy and comprehensively assess its impact on the gut microbiome-NOD2 pathway, intestinal inflammation, and the progression of IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with ulcerative colitis (UC) Patients diagnosed with UC according to the 'Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)'.
- •Patients with non-infectious UC initially diagnosed through laboratory tests, endoscopy, and pathological biopsy;
- •According to the latest guideline standards, clinically diagnosed with mild to moderate disease; defined as a modified Mayo score of 3-9 points; and classified as mild to moderate based on the modified Truelove and Witts severity classification;
- •In the active phase, with a clinical treatment plan using only mesalazine;
- •Voluntarily participating in this clinical trial, understanding, and signing the informed consent form.
- •2. Patients with Crohn's disease (CD) Patients diagnosed with Crohn's disease (CD) according to the 'Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)'.
- •Patients with non-infectious Crohn's disease (CD) initially diagnosed through laboratory tests, endoscopic examination, and pathological biopsy;
- •Clinically diagnosed as having mild to moderate disease according to the latest guideline standards, defined as a Crohn's Disease Activity Index (BestCDAI) score of 150-450;
- •Voluntarily participating in this clinical trial, having understood and signed the informed consent form.
排除标准
- •1. Patients with ulcerative colitis (UC) Patients diagnosed with UC according to the 'Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)'.
- •Patients who have changed medication dosage or type in the past 2 months;
- •Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
- •Patients who have the history of immunosuppressive drugs such as methotrexate or glucocorticoids ;
- •Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
- •Patients who have Concurrent active infections, including but not limited to obvious gastrointestinal bleeding, local or systemic infectious symptoms due to severe gastrointestinal ulceration or bleeding;
- •Pregnant or preparing for pregnancy and breastfeeding women;
- •Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.
- •2. Patients with Crohn's disease (CD) Patients diagnosed with Crohn's disease (CD) according to the 'Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)'.
- •Patients who have changed medication dosage or type in the past 2 months;
- •Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
- •Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
- •Patients who have Concurrent active infections, including but not limited to obvious gastrointestinal bleeding, local or systemic infectious symptoms due to severe gastrointestinal ulceration or bleeding;
- •Pregnant or preparing for pregnancy and breastfeeding women;
- •Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.
研究组 & 干预措施
Experimental group
Take 2 grams of probiotic powder(LR607) daily from day 1 to day 5, and 4 grams daily from day 6 to day 90.
干预措施: Lactobacillus rhamnosus CALM 607（LR607） (Dietary Supplement)
Control
Take 2 grams of placebo daily from days 1 to 5, and 4 grams daily from days 6 to 90.
结局指标
主要结局
Modified Mayo endoscopic score
时间窗: 3 months
Modified Mayo endoscopic score is divided into diarrhea, blood in stool, mucosal appearance, and physician assessment, each with a score of 0 to 3. * Clinical remission: score \<2 with no individual subscore \>1 ; * Mild activity: 3-5 points; * Moderate activity: 6-10 points; * Severe activity: 11-12 points
次要结局
- The changes in gut microbiota structure(3 months)
- The Levels of NOD2 in the gut(3 months)
- Endoscopic scoring（SES⁃CD/UCEIS）(3 months)
研究者
Hongwei Zhou
Shenzhen Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University