Small Intestinal Bacterial OvergrowthNCT06162702
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
A study testing Fecal microbiota transplantation in people with Small Intestinal Bacterial Overgrowth and Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Fecal Microbiota Transplantation
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Shanghai
About this study
Official title: 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.
- Being tested
- Fecal microbiota transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| FMT Responder | Experimental | Not described Receives: Procedure: Fecal microbiota transplantation |
| FMT non-Responder | Experimental | Not described Receives: Procedure: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 days, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Sep 2022
- Primary completion10 Oct 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162702
- Sponsor's protocol ID
- FMT-SIBO
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO).
- ClinicalTrials.gov ID
- NCT06162702
- Acronym / sponsor ID
- FMT-SIBO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT Responder | Experimental | Procedure: Fecal microbiota transplantation |
| FMT non-Responder | Experimental | Procedure: Fecal microbiota transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationFecal 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. | Procedure or surgery | FMT Responder, FMT non-Responder |
Primary outcome
Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)
Time frame: 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
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Small Intestinal Bacterial Overgrowth and Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (Assessing the safety of FMT in patients with SIBO) (time frame: 7 days, 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.