Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- IBS-SSS score
研究概览
简要总结
In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.
详细描述
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.
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
- Single (Outcomes Assessor)
盲法说明
The assessor of the scale does not know the grouping of patients when assessing the patient.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 ~ 75 years.
- •Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.
- •IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.
- •No other serious diseases, no mental disorders, and normal communication skills.
- •Sign informed consent and agree to participate in this study.
- •No antibiotics and probiotics were used within one month.
排除标准
- •Patients are unwilling to participate in this study.
- •Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.
- •Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.
- •Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.
- •There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.
- •Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts.
- •History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy).
- •Those who were allergic to capsule drugs or contraindications.
- •Lactose intolerance.
- •Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment.
- •It is difficult to complete the follow-up, or various factors affecting the compliance.
- •Pregnant or lactating women.
结局指标
主要结局
IBS-SSS score
时间窗: 12 Week after treatment
Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.
次要结局
- Clinical remission rate(2、4、8、12 Week after treatment)
- PHQ-9(0、2、4、8、12Week after treatment)
- Intestinal flora(0、2、4、8、12Week after treatment)
- GSRS score(0、2、4、8、12Week after treatment)
- SAS(0、2、4、8、12Week after treatment)
- SDS(0、2、4、8、12after treatment)
- IBS-QoL score(0、2、4、8、12Week after treatment)
- GAD-7(0、2、4、8、12Week after treatment)
研究者
Yanling Wei
Department of Gastroenterology, Da ping Hospital, The Third Military Medical University
Third Military Medical University