The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The degree of microbiota correction or improvement by specific probiotic strain(s)
研究概览
简要总结
People nowadays tend to have irregular diet and routine due to the stress at work. This condition may cause intestinal microflora imbalance, and in the long term may lead to constipation, diarrhea, gastroenteritis, gastric ulcer and other gastrointestinal diseases. Helicobacter pylori infection, which can trigger gastrointestinal inflammation and ulcer, is commonly treated by antibiotics. This treatment, however, can reduce the diversity of the intestinal microflora, causing diarrhea, flatulence and nausea. Clinical trials showed that probiotics and prebiotics supplementation could regulate gastrointestinal function, including alleviating constipation, ameliorating antibiotic-associated diarrhea and flatulence, enhancing the effect of H. pylori treatment, and restoring the balance of intestinal microflora. This Probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years. This project aims to observe the effectiveness of Probiotics product consumption by H. pylori-infected patients in relieving the gastrointestinal symptoms and restoring their intestinal microflora.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(PART I : For patients with bowel disorders):
- •Constipation : Must include 2 or more of the following:
- •straining during at least 25% of defecations
- •lumpy or hard stools in at least 25% of defecations
- •sensation of incomplete evacuation for at least 25% of defecations
- •sensation of anorectal obstruction/blockage for at least 25% of defecations
- •manual maneuvers to facilitate at least 25% of defecations
- •fewer than 3 defecations per week
- •Diarrhea :
- •the passage of 3 or more loose or liquid stools per day and lasting more than 1 week, or more frequently than is normal for the individual.
- •Inclusion Criteria (PART II : For patients with Helicobacter pylori infection):
- •Campylobacter-like organism test (CLO test) positive
排除标准
- •(PART I & II)
- •prior upper digestive tract surgery
- •a history of cancer
- •lactose intolerance
- •allergy to penicillin
- •prior antibiotics therapy in the last month
- •prior probiotics supplement more than once a week in the last three weeks
研究组 & 干预措施
Probiotics product
干预措施: Probiotics product (Dietary Supplement)
Placebo
干预措施: Probiotics product (Dietary Supplement)
结局指标
主要结局
The degree of microbiota correction or improvement by specific probiotic strain(s)
时间窗: Changes from Baseline Fecal Microbiota at 4 weeks
16S ribosomal RNA (rRNA) sequencing is a common amplicon sequencing methods used to identify and compare bacteria present within a given sample. 16S rRNA gene sequencing is a well-established method for comparing sample phylogeny and taxonomy from complex microbiomes.
Questionnaire to assess the severity and frequency of symptoms was reported
时间窗: Changes from Baseline GSRS at 4 weeks
The Gastrointestinal Symptom Rating Scale (GSRS) is a disease-specific questionnaire of 15 items to assess the severity and frequency of symptoms was reported; GSRS uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem.
次要结局
未报告次要终点
研究者
Ching-Chiang, Lin
professor
Fooyin University