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

Irritable Bowel Syndrome Clinical Trial

Official title:

Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02651740
• Other study ID #: SXZ-WSD01-2015
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2016
• Est. completion date: December 2023

Study information

• Verified date: December 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Shengdi Wu
• Phone: (86)13817923359
• Email: wu.shengdi[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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: ?Abdominal pain (at least 2 days in a week with no limitation of severity); ?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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Rifaximin
400mg tid* 3d

Procedure:
• Fecal microbiota transplantation
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate and type of adverse effects	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	The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment
Primary	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	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	1 month/2 month/3 month/6 month after the treatment
Secondary	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.	2 week/1 month/2 month/3 month/6 month after the treatment