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

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ClinicalTrials.gov Identifier: NCT02651740
Recruitment Status : Unknown
Verified September 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Number of patients with relief of IBS condition [ Time Frame: 6 months after the treatment ]
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) ).
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
Number of patients with relief of IBS core symptoms ( abdominal pain and stool consistency ) [ Time Frame: 4 weeks after the treatment ]
The proportion of patients who have relief of abdominal pain (daily assessed according to 0-10 point scoring system, with 0 indicating no pain at all and 10 indicating very great deal of pain, patients record the most severe pain in a day) and stool consistency (according to Bristol type) during the 4 weeks after the treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Number of patients with relief of IBS related anxiety or depression status [ Time Frame: 1 month/2 month/3 month/6 month after the treatment ]
    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 [ Time Frame: 2 week/1 month/2 month/3 month/6 month after the treatment ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Number of patients with relief of other specific IBS symptoms besides abdominal pain and stool consistency ( including global IBS symptoms, stool frequency and IBS-related bloating ) [ Time Frame: 4 weeks after the treatment ]
    The proportion of patients who have relief of global IBS symptoms、 stool frequency、IBS-related bloating during the 4 weeks after the treatment.
  • Number of patients with relief of any IBS-related syptoms( including global IBS symptoms, abdominal pain, bloating, stool consistency and frequency ) [ Time Frame: 12 weeks after the treatment ]
    The proportion of patients who have relief of global IBS symptoms、abdominal pain/bloating/stool consistency/stool frequency during the 12 weeks after the treatment.
  • Number of patients with improvement of quality of life [ Time Frame: 4/12/24 weeks after the treatment ]
    The improvement of quality of life is measured by SF36-V2 and EQ-5D
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2017)
The rate and type of adverse effects [ Time Frame: The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment ]
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
Original Other Pre-specified Outcome Measures
 (submitted: January 8, 2016)
The rate and type of adverse effects [ Time Frame: The last day of the treatment and 4/8/12/24 weeks after the treatment ]
It means any events that occur in the trial process related or unrelated to the drug/FMT that do harm to the patients' health, including symptoms/physical signs/abnormal lab values
 
Descriptive Information
Brief Title  ICMJE Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
Official Title  ICMJE Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Rifaximin
    400mg tid* 3d
    Other Name: Brand name: XIFAXAN; Production company: SALIX PHARMS
  • Procedure: Fecal microbiota transplantation
    Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
Study Arms  ICMJE Experimental: Combining therapy
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
Interventions:
  • Drug: Rifaximin
  • Procedure: Fecal microbiota transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2016)
200
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651740
Other Study ID Numbers  ICMJE SXZ-WSD01-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xizhong Shen, PhD Zhongshan Hospital, Shanghai, China
PRS Account Shanghai Zhongshan Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP