Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2030-12-31

Brief Summary

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Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

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Detailed Description

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The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.

Conditions

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Irritable Bowel Syndrome Fecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Masking only Participant

Study Groups

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fecal microbiota transplantation

Group Type EXPERIMENTAL

fecal microbiota transplantation

Intervention Type PROCEDURE

200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

placebo fecal microbiota transplantation

Infusion of sham

Group Type SHAM_COMPARATOR

Infusion of sham

Intervention Type PROCEDURE

Infusion of sham

Traditional treatments

Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants

Group Type SHAM_COMPARATOR

probiotics, antibiotics or antidepressants

Intervention Type DRUG

Drugs such as probiotics, antibiotics, antidepressants

Interventions

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fecal microbiota transplantation

200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

Intervention Type PROCEDURE

Infusion of sham

Intervention Type PROCEDURE

probiotics, antibiotics or antidepressants

Drugs such as probiotics, antibiotics, antidepressants

Intervention Type DRUG

Other Intervention Names

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rifaximin Clostridium butyricum TO-A

Eligibility Criteria

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Inclusion Criteria

To be considered eligible for enrolment into the study, subjects must:

* Be able to give written informed consent.
* Males and females aged \>18 and \<75
* Have IBS as defined by the Rome IV criteria

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the below criteria:

* pregnant or having a follow-up of less than 6 months;
* unable to give informed consent;
* suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
* unable to undergo endoscopy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No