Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Fudan University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Rifaximin

Procedure: Fecal microbiota transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02651740

SXZ-WSD01-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.