fecal microbiota transplantationInfusion of shamprobiotics, antibiotics or antidepressants
fecal microbiota transplantation: 200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
Infusion of sham: Infusion of sham
probiotics, antibiotics or antidepressants: Drugs such as probiotics, antibiotics, antidepressants
Study summary
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must:
* Be able to give written informed consent.
* Males and females aged \>18 and \<75
* Have IBS as defined by the Rome IV criteria
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria:
* pregnant or having a follow-up of less than 6 months;
* unable to give informed consent;
* suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
* unable to undergo endoscopy.
Primary outcome measure(s)
Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) — baseline; one month;three months;six months This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :\<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and \> 300 indicated severe IBS .
Trial sites (1)
Facility
City
Region
Status
Guangzhou First People's Hospital
Guangzhou
Guangdong
Recruiting
More Guangzhou First People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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