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

NCT02651740 | Unknown Phase 2 DMC

• 1 other identifier: SXZ-WSD01-2015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Rifaximin; Fecal microbiota transplantation; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Number of patients with relief of IBS condition

  The "responder" should at the same time get relief of at least one item of abdominal discomfort related symptoms(including abdominal pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain) and bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), both items' effectiveness are defined as decreasing at least 30% compared with baseline) and at least one item of defecation related abnomalities(including average daily defecation(effectiveness defined as decreasing at least 30% compared with baseline) and stool consistency(effectiveness defined as feces could reach at least Bristol type 5) ).

  6 months after the treatment

Secondary Outcomes (2)

• Number of patients with relief of IBS related anxiety or depression status

  1 month/2 month/3 month/6 month after the treatment

• Number of patients with relief of IBS single symptoms

  2 week/1 month/2 month/3 month/6 month after the treatment

Other Outcomes (1)

• The rate and type of adverse effects

  The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment

Study Arms (1)

Combining therapy

EXPERIMENTAL

taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube

Drug: Rifaximin; Procedure: Fecal microbiota transplantation

Interventions

Rifaximin DRUG

400mg tid\* 3d

Also known as: Brand name: XIFAXAN; Production company: SALIX PHARMS

Combining therapy

Fecal microbiota transplantation PROCEDURE

Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time

Combining therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Rifaximin; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Biological Therapy; Therapeutics

Study Officials

• Xizhong Shen, PhD

  Zhongshan Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Shengdi Wu

CONTACT

(86)13817923359; wu.shengdi@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 11, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

CN (1)