Clinical trial NCT03613545: Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Fecal Microbiota Transplantation
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)
timeFrame: baseline; one month;three months;six months
Secondary outcomes:
measure: Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores
timeFrame: baseline; one month;three months;six months
measure: Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA)
timeFrame: baseline; one month;three months;six months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Hongli Huang, MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Distrutti E, Monaldi L, Ricci P, Fiorucci S. Gut microbiota role in irritable bowel syndrome: New therapeutic strategies. World J Gastroenterol. 2016 Feb 21;22(7):2219-41. doi: 10.3748/wjg.v22.i7.2219.