Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
NCT ID: NCT02651740
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2016-04-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combining therapy
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
Rifaximin
400mg tid\* 3d
Fecal microbiota transplantation
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
Interventions
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Rifaximin
400mg tid\* 3d
Fecal microbiota transplantation
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Xizhong Shen, PhD
Role: STUDY_CHAIR
Zhongshan Hospital, Shanghai, China
Locations
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Zhongshan Hospital, Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shengdi Wu
Role: primary
Other Identifiers
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SXZ-WSD01-2015
Identifier Type: -
Identifier Source: org_study_id