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

Fecal Microbiota Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06162702
• Other study ID #: FMT-SIBO
• Status: Completed
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation
• Small Intestinal Bacterial Overgrowth

Intervention

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.

Locations

Country	Name	City	State
China	Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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