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Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

NCT ID: NCT06162702

Last Updated: 2023-12-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-10

Study Completion Date

2023-11-10

Brief Summary

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Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive numbers of bacteria in the small bowel causing gastrointestinal (GI) symptoms. These bacteria are usually coliforms, which are typically found in the colon and include predominantly Gram-negative aerobic and anaerobic species that ferment carbohydrates producing gas .Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of SIBO.

Detailed Description

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Conditions

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Small Intestinal Bacterial Overgrowth Fecal Microbiota Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FMT Responder

Group Type EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type PROCEDURE

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

FMT non-Responder

Group Type EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type PROCEDURE

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

Interventions

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Fecal microbiota transplantation

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with a positive breath test result upon initial admission.
* Patients presenting with abdominal symptoms.
* Patients who have stool and small intestinal fluid samples available before and after FMT.

Exclusion Criteria

* Patients with gastrointestinal malignancies.
* Patients with a history of gastrointestinal surgery.
* Patients on long-term probiotic use.
* Patients with a history of extensive antibiotic use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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FMT-SIBO

Identifier Type: -

Identifier Source: org_study_id