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

To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO).

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.

Study Overview

• Status: Completed
• Conditions: Small Intestinal Bacterial Overgrowth; Fecal Microbiota Transplantation
• Intervention / Treatment: Procedure: Fecal microbiota transplantation

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT Responder	Procedure: 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.
Experimental: FMT non-Responder	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)	Document adverse events related to FMT that occurred during the study, including their frequency and severity.	7 days, 1 month
Number of Patients with gastrointestinal symptom scores	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.	7 days, 1 month
Investigating the impact of FMT on the colonic and small intestinal microbiota.	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.	7 days, 1 month

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FMT-SIBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No