Fecal Microbiota Transplantation for Irritable Bowel Syndrome
- Conditions
- Irritable Bowel SyndromeFecal Microbiota Transplantation
- Interventions
- Drug: probiotics, antibiotics or antidepressantsProcedure: fecal microbiota transplantationProcedure: Infusion of sham
- Registration Number
- NCT03613545
- Lead Sponsor
- Guangzhou First People's Hospital
- Brief 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.
- Detailed Description
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional treatments probiotics, antibiotics or antidepressants Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants fecal microbiota transplantation fecal microbiota transplantation fecal microbiota transplantation placebo fecal microbiota transplantation Infusion of sham Infusion of sham
- Primary Outcome Measures
Name Time Method 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 .
- Secondary Outcome Measures
Name Time Method Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA) baseline; one month;three months;six months The Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) were used to evaluate the mental and psychological states of patients. HAMD scores were graded as follows: 8-19, mild depression; 20-34, moderate depression; ≥35, severely depression. HAMA scores were graded as follows: 14-20, mild anxiety; 21-28, moderate anxiety;≥29 , severe anxiety.
Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores baseline; one month;three months;six months The IBS-QOL questionnaire consisted of 34 items, covering eight aspects (dysphoria, interference with activity, body image, health worry, food avoidance,social reaction, sexual dysfunction, and relationships). Each item was rated on a 5-point Likert scale(1 = not at all, 5 = a great deal). Total scores were transformed to a 0±100 scale ranging from 0 (maximum quality of life) to 100 (poor quality of life).
Trial Locations
- Locations (1)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China