Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
2021年5月17日 更新者：Yanling Wei
Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yanling Wei
- 电话号码：15310354666
- 邮箱：lingzi016@126.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：FMT group
Standardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules.
The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria.
|
The group includes 35 patients.
They will receive standardized FMT.
Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally.
It was given only once.
|
|
实验性的：JZ group
1.6g Po perday,for 28 days.
probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days.
|
The group includes 35 patients.
They will receive Precision Flora Transplantation.
They were used self-developed precision transplant capsules for precision flora transplantation.
4 capsules are used each time.
Each capsule contains 400mg of various probiotics effective against diarrhea.
It is used orally, once a day,for 28 days.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
IBS-SSS score
大体时间：12 Week after treatment
|
Severity of irritable bowel syndrome.The score varies from 0 to 500.
Higher scores suggest more severe condition.
|
12 Week after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical remission rate
大体时间：2、4、8、12 Week after treatment
|
Proportion of people in clinical remission after treatment
|
2、4、8、12 Week after treatment
|
|
GSRS score
大体时间：0、2、4、8、12Week after treatment
|
Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112.
Higher scores suggest more severe gastrointestinal pathology.
|
0、2、4、8、12Week after treatment
|
|
IBS-QoL score
大体时间：0、2、4、8、12Week after treatment
|
Quality of life score for IBS patients.The score varies from 0 to 136.
Higher scores suggest greater impact of disease on life
|
0、2、4、8、12Week after treatment
|
|
PHQ-9
大体时间：0、2、4、8、12Week after treatment
|
Patient Health Questionnaire-9.The score varies from 0 to 27.
Higher scores suggest more severe the depression
|
0、2、4、8、12Week after treatment
|
|
GAD-7
大体时间：0、2、4、8、12Week after treatment
|
Generalized Anxiety Scale-7.The score varies from 0 to 21.
Higher scores suggest heavier the anxiety.
|
0、2、4、8、12Week after treatment
|
|
SAS
大体时间：0、2、4、8、12Week after treatment
|
Self-rating Anxiety Scale.The score varies from 25 to 100.
Higher scores suggest greater degree of anxiety.
|
0、2、4、8、12Week after treatment
|
|
SDS
大体时间：0、2、4、8、12after treatment
|
Self-rating Depression Scale.The score varies from 25 to 100.
Higher scores suggest more severe depression.
|
0、2、4、8、12after treatment
|
|
Intestinal flora
大体时间：0、2、4、8、12Week after treatment
|
Use metagenomics technology to detect intestinal flora
|
0、2、4、8、12Week after treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Yanling Wei、Army Medical Center of PLA
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年5月20日
初级完成 (预期的)
2021年10月1日
研究完成 (预期的)
2022年10月1日
研究注册日期
首次提交
2021年5月5日
首先提交符合 QC 标准的
2021年5月17日
首次发布 (实际的)
2021年5月18日
研究记录更新
最后更新发布 (实际的)
2021年5月18日
上次提交的符合 QC 标准的更新
2021年5月17日
最后验证
2021年5月1日
更多信息
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