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

Tongji University

Status: Completed

Conditions: Small Intestinal Bacterial Overgrowth; Fecal Microbiota Transplantation

Treatments: Procedure: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06162702

FMT-SIBO

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

FMT Responder

Experimental group

Treatment:

Procedure: Fecal microbiota transplantation

FMT non-Responder

Experimental group

Treatment:

Procedure: Fecal microbiota transplantation