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

Not Applicable

Completed

• Conditions: Fecal Microbiota Transplantation; Small Intestinal Bacterial Overgrowth
• Interventions: Procedure: Fecal microbiota transplantation

• Registration Number: NCT06162702
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-09-10
• Primary Completion: 2023-10-10
• Status Verified: 2023-11
• Study Completion: 2023-11-10
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT Responder	Fecal microbiota transplantation	-
FMT non-Responder	Fecal microbiota transplantation	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)	7 days, 1 month	Document adverse events related to FMT that occurred during the study, including their frequency and severity.
Number of Patients with gastrointestinal symptom scores	7 days, 1 month	The efficacy of FMT in SIBO patients was evaluated according to the scores of gastrointestinal symptoms before and after treatment. Patients with gastrointestinal symptom scores, including some of the abdominal symptoms and defecation situation, we can according to this questionnaire to assess patients with abdominal symptoms and defecate on the improvement of their situation.
Investigating the impact of FMT on the colonic and small intestinal microbiota.	7 days, 1 month	For patients before and after the FMT feces and small intestinal juice samples 16 s rRNA sequencing, compare the difference between before and after the FMT feces and bacteria in the intestinal flora of diversity, species composition belong. The changes of commensal bacteria, opportunistic pathogens and pathogenic bacteria in feces and small intestinal fluid after FMT were compared.

Trial Locations

Locations (1)

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