Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
2021년 5월 17일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (예상)
70
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yanling Wei
- 전화번호: 15310354666
- 이메일: lingzi016@126.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
IBS-SSS score
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical remission rate
기간: 2、4、8、12 Week after treatment
|
Proportion of people in clinical remission after treatment
|
2、4、8、12 Week after treatment
|
|
GSRS score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 0、2、4、8、12Week after treatment
|
Use metagenomics technology to detect intestinal flora
|
0、2、4、8、12Week after treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Yanling Wei, Army Medical Center of PLA
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2021년 5월 20일
기본 완료 (예상)
2021년 10월 1일
연구 완료 (예상)
2022년 10월 1일
연구 등록 날짜
최초 제출
2021년 5월 5일
QC 기준을 충족하는 최초 제출
2021년 5월 17일
처음 게시됨 (실제)
2021년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 17일
마지막으로 확인됨
2021년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Standardized FMT에 대한 임상 시험
-
University GhentUniversity Hospital, Ghent; Research Foundation Flanders; the Flanders Institute for Biotechnology 그리고 다른 협력자들완전한
-
Fondazione Policlinico Universitario Agostino Gemelli...모병
-
Fondazione Policlinico Universitario Agostino Gemelli...모병
-
Aleris-Hamlet Hospitaler KøbenhavnUniversity of Aarhus; Hvidovre University Hospital완전한
-
McMaster UniversitySt. Joseph's Healthcare Hamilton; Hamilton Health Sciences Corporation; Queen's University; Vancouver General Hospital완전한
-
Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, Belgium알려지지 않은
-
University of North Carolina, Chapel HillThe Broad Foundation; Crohn's and Colitis Foundation; OpenBiome종료됨