Small Intestine Bacterial OvergrowthPhase 1/2NCT06518850
Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
A Phase 1/2 study testing Rifaximin in people with Small Intestine Bacterial Overgrowth, run by Peking Union Medical College Hospital.
Trial summary
Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Small Intestine Bacterial Overgrowth
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- Age 18-60 years old and gender;
- The chief complaint is abdominal distension and/or abdominal distension, abdominal distension and/or abdominal distension more prominent than other symptoms.
- Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
- Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
- No drug contraindications.
Who cannot join
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
- History of malignant tumors, history of abdominal surgeries;
- Food intolerance, confirmed or suspected lactose intolerance;
- Diagnosis of urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.) and other diseases outside the digestive system;
- Antibiotics and microecological preparations should be used within two weeks. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
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- Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
- Antibiotics and microecological preparations should be used within two weeks;
- Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicentre Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Abdominal Distension Patients
Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. On this basis, patients with functional abdominal distension complicated with small intestine bacterial overgrowth were divided according to whether there was abnormal oral cecum transit time, and given the same treatment plan. The relief effect of abdominal distension, small intestine bacterial overgrowth turning negative and oral cecum transit time recovery were observed, so as to further clarify the cause of abdominal distension patients.
Read the detailed description
Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies The clinical characteristics of small intestine bacterial overgrowth and oral cecum transit time in patients with abdominal distention of different etiology (organic and functional) were studied to lay a foundation for further exploration of treatment of functional abdominal distention.
Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth To observe the effect of antibiotics on abdominal distension in patients with functional abdominal distension complicated with small intestine bacterial overgrowth, and observe the effect of rifaximin on small intestine bacterial overgrowth and oral cecum transit time, so as to provide new ideas for the diagnosis and treatment of abdominal distension patients.
- Conditions
- Small Intestine Bacterial Overgrowth
- Being tested
- Rifaximin
- Keywords
- small intestine bacterial overgrowth, oral cecum transit time, abdominal distention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Both groups were treated with rifaximin for 14 days, during which follow-up records were reported by the subjects in the daily reference case report form. Methane and hydrogen breath tests were repeated 2 weeks after withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator（Normal oral cecum transit time） | Sham comparator | Normal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment. Receives: Drug: Rifaximin |
| Experimental（Abnormal oral cecum transit time） | Experimental | Abnormal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment. Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Positive rate of small intestinal bacterial overgrowth
Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension
Measured: 1 day
Part 1 Abnormal rate of oral cecum transit time
Abnormal rate of oral cecum transit time in organic and functional abdominal distension
Measured: 1 day
Part 2 Effective rate of abdominal distension
Total effective rate (%) = Obvious effective rate (%) + Effective rate (%)
- Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative
- Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive
- Ineffective: the degree and frequency of abdominal distension score did not improve
Measured: 2 weeks
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time
- Negative conversion rate of small intestinal bacterial overgrowth (%) =Number of small intestinal bacterial overgrowth negative after treatment/ Number of functional abdominal distention in Part 2*100%
- Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2*100%
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine Bacterial OvergrowthStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Air Force Military Medical University, China, Beijing Tongren Hospital, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, The Luhe Teaching Hospital of the Capital Medical University, China-Japan Friendship Hospital, Beijing Aerospace General Hospital, Beijing Jishuitan Hospital, Peking University Third Hospital
- Responsible party
- Principal investigator, Jing-Nan Li, Peking Union Medical College Hospital
- Investigators
- Jing-Nan Li, MD,Ph.D, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518850
- Sponsor's protocol ID
- I-23PJ1228
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Abdominal Distension Patients
- ClinicalTrials.gov ID
- NCT06518850
- Acronym / sponsor ID
- I-23PJ1228
- Conditions
- Small Intestine Bacterial Overgrowth
- Keywords
- small intestine bacterial overgrowth, oral cecum transit time, abdominal distention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Air Force Military Medical University, China, Beijing Tongren Hospital, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, The Luhe Teaching Hospital of the Capital Medical University, China-Japan Friendship Hospital, Beijing Aerospace General Hospital, Beijing Jishuitan Hospital, Peking University Third Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jul 2024 (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.
Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. On this basis, patients with functional abdominal distension complicated with small intestine bacterial overgrowth were divided according to whether there was abnormal oral cecum transit time, and given the same treatment plan. The relief effect of abdominal distension, small intestine bacterial overgrowth turning negative and oral cecum transit time recovery were observed, so as to further clarify the cause of abdominal distension patients.
Detailed description
Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies The clinical characteristics of small intestine bacterial overgrowth and oral cecum transit time in patients with abdominal distention of different etiology (organic and functional) were studied to lay a foundation for further exploration of treatment of functional abdominal distention.
Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth To observe the effect of antibiotics on abdominal distension in patients with functional abdominal distension complicated with small intestine bacterial overgrowth, and observe the effect of rifaximin on small intestine bacterial overgrowth and oral cecum transit time, so as to provide new ideas for the diagnosis and treatment of abdominal distension patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator（Normal oral cecum transit time） | Sham comparator | Drug: RifaximinNormal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment. |
| Experimental（Abnormal oral cecum transit time） | Experimental | Drug: RifaximinAbnormal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- Age 18-60 years old and gender;
- The chief complaint is abdominal distension and/or abdominal distension, abdominal distension and/or abdominal distension more prominent than other symptoms.
- Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
- Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
Key exclusion criteria (9 listed)
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
- History of malignant tumors, history of abdominal surgeries;
- Food intolerance, confirmed or suspected lactose intolerance;
- Diagnosis of urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.) and other diseases outside the digestive system;
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 |
|---|---|---|
| RifaximinBoth groups were treated with rifaximin for 14 days, during which follow-up records were reported by the subjects in the daily reference case report form. Methane and hydrogen breath tests were repeated 2 weeks after withdrawal. | Drug | Experimental（Abnormal oral cecum transit time）, Sham Comparator（Normal oral cecum transit time） |
Primary outcome
Part 1 Positive rate of small intestinal bacterial overgrowth
Time frame: 1 day
Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension
Part 1 Abnormal rate of oral cecum transit time
Time frame: 1 day
Abnormal rate of oral cecum transit time in organic and functional abdominal distension
Part 2 Effective rate of abdominal distension
Time frame: 2 weeks
Total effective rate (%) = Obvious effective rate (%) + Effective rate (%) 1. Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative 2. Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive 3. Ineffective: the degree and frequency of abdominal distension score did not improve
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time
Time frame: 2 weeks
1. Negative conversion rate of small intestinal bacterial overgrowth (%) =Number of small intestinal bacterial overgrowth negative after treatment/ Number of functional abdominal distention in Part 2*100% 2. Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2*100%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
Jing-Nan Li, MD,Ph.D principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rifaximin in people with Small Intestine Bacterial Overgrowth, run by Peking Union Medical College Hospital.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Nan Li, MD,Ph.D (13601235229, Jing-NanLilijn2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Positive rate of small intestinal bacterial overgrowth (time frame: 1 day). The study lists 4 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 24 Jul 2024.