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

NCT06162702 | Completed

• 1 other identifier: FMT-SIBO
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Bacterial Overgrowth; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

FMT Responder

EXPERIMENTAL

Procedure: Fecal microbiota transplantation

FMT non-Responder

EXPERIMENTAL

Procedure: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation 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 Responder; FMT non-Responder

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

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

Shanghai, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: September 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)