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

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Fecal microbiota transplantation
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Rifaximin, Fecal microbiota transplantation, Gut microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combining therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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) ).

Secondary Outcome Measures

Number of patients with relief of IBS related anxiety or depression status
The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale
Number of patients with relief of IBS single symptoms
The number of patients who have relief of IBS global score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain), bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicateds very great deal of discomfort), urgency score(0-3 with 0 indicates no urgency and 3 indicates great deal of urgency), average daily defecation, stool consistency(according to Bristol criteria). Except stool consistency, other items' effectiveness are defined as decreasing at least 30% compared with baseline during the whole period of follow-up. Stool consistency's effectiveness is defined as feces could reach at least Bristol type 5 during the whole period of follow-up.

Full Information

First Posted
January 6, 2016
Last Updated
December 29, 2021
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02651740
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Rifaximin, Fecal microbiota transplantation, Gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combining therapy
Arm Type
Experimental
Arm Description
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Brand name: XIFAXAN; Production company: SALIX PHARMS
Intervention Description
400mg tid* 3d
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
Primary Outcome Measure Information:
Title
Number of patients with relief of IBS condition
Description
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) ).
Time Frame
6 months after the treatment
Secondary Outcome Measure Information:
Title
Number of patients with relief of IBS related anxiety or depression status
Description
The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale
Time Frame
1 month/2 month/3 month/6 month after the treatment
Title
Number of patients with relief of IBS single symptoms
Description
The number of patients who have relief of IBS global score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain), bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicateds very great deal of discomfort), urgency score(0-3 with 0 indicates no urgency and 3 indicates great deal of urgency), average daily defecation, stool consistency(according to Bristol criteria). Except stool consistency, other items' effectiveness are defined as decreasing at least 30% compared with baseline during the whole period of follow-up. Stool consistency's effectiveness is defined as feces could reach at least Bristol type 5 during the whole period of follow-up.
Time Frame
2 week/1 month/2 month/3 month/6 month after the treatment
Other Pre-specified Outcome Measures:
Title
The rate and type of adverse effects
Description
It means any events that occur in the trial process related or unrelated to the drug/fecal microbiota transplantation that do harm to the patients' health, including symptoms/physical signs/abnormal lab values
Time Frame
The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengdi Wu
Phone
(86)13817923359
Email
wu.shengdi@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xizhong Shen, PhD
Organizational Affiliation
Zhongshan Hospital, Shanghai, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengdi Wu
Phone
(86)13817923359
Email
wu.shengdi@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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