Overview

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

Status:
Unknown status
Trial end date:
2020-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Zhongshan Hospital
Treatments:
Rifamycins
Rifaximin
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: â‘ Abdominal pain (at least 2 days in a week with no
limitation of severity); â‘¡Stool 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.