Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of effective patients with functional constipation and irritable bowel syndrome patients
研究概览
简要总结
The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing for colonoscopy
- •Meet Rome IV diagnostic criteria for functional constipation or irritable bowel syndrome
- •Voluntarily participate in this clinical study and sign the informed consent.
排除标准
- •Use of probiotics or antibiotics within the past 4 weeks
- •History of intestinal surgery
- •History of severe liver and kidney disease
- •History of cardiovascular and cerebrovascular diseases
- •History of neuropsychiatric diseases
- •Pregnant women or lactating women
- •Allergic to any ingredients of the live bacteria tablet
研究组 & 干预措施
Live Combined Bifidobacterium and Lactobacillus
The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
干预措施: Live Combined Bifidobacterium and Lactobacillus (Drug)
Live Combined Bifidobacterium and Lactobacillus
The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
干预措施: Basic treatment (Drug)
Control
The control group receive basic treatment and a single injection of normal saline through colonoscopy.
干预措施: Normal saline (Drug)
Control
The control group receive basic treatment and a single injection of normal saline through colonoscopy.
干预措施: Basic treatment (Drug)
结局指标
主要结局
Proportion of effective patients with functional constipation and irritable bowel syndrome patients
时间窗: 8-12 weeks after start of treatment.
The efficacy of irritable bowel syndrome is evaluated by stool texture and abdominal discomfort related scales including IBS-SSS, BSS score, IBS-QOL,HADS and number of bowel movements per day in 12 weeks after start of treatment. The efficacy of functional constipation is evaluated by weekly defecation frequency, spontaneous complete bowel movement, and scales such as Wexner constipation score, BSS score, and PAC-QOL in 8 weeks after start of treatment.
次要结局
- Incidence of adverse events related to treatment(8-12 weeks after start of treatment.)
