Clinical trial NCT02651740: Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
Official title: Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Rifaximin
Fecal microbiota transplantation
Gut microbiota
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.

Detailed description: In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65, no gender limitation;
* Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
* Has current symptoms of IBS-D: ①Abdominal pain (at least 2 days in a week with no limitation of severity); ②Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week);
* Can do follow-up at required time points and signed written informed consent before the study.

Exclusion Criteria:

* Allergic to rifaximin;
* Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
* Had infective diarrhea history or had taken antibiotics within the previous 14 days;
* Patients with a history of inflammatory bowel disease ;
* Previous abdominal surgery (other than cholecystectomy or appendectomy);
* Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
* Unstable diabetes, hypertension, thyroid disease, etc;
* Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
* Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
* Other conditions that doctor thought not suitable for the study.

Primary outcomes:
measure: Number of patients with relief of IBS condition
timeFrame: 6 months after the treatment
Secondary outcomes:
measure: Number of patients with relief of IBS related anxiety or depression status
timeFrame: 1 month/2 month/3 month/6 month after the treatment
measure: Number of patients with relief of IBS single symptoms
timeFrame: 2 week/1 month/2 month/3 month/6 month after the treatment
Other outcomes:
measure: The rate and type of adverse effects
timeFrame: The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Zhongshan Hospital, Shanghai, China
name: Xizhong Shen, PhD
role: STUDY_CHAIR
References: