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

Phase 2

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Rifaximin; Procedure: Fecal microbiota transplantation

• Registration Number: NCT02651740
• Lead Sponsor: Shanghai Zhongshan Hospital

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 Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Study Start: 2016-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combining therapy	Fecal microbiota transplantation	taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
Combining therapy	Rifaximin	taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube

Primary Outcome Measures

Name	Time	Method
Number of patients with relief of IBS condition	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) ).

Secondary Outcome Measures

Name	Time	Method
Number of patients with relief of IBS related anxiety or depression status	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	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.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China