Small Intestinal Bacterial OvergrowthNCT06483360
Methane and Hydrogen Breath Test for the Diagnosis of Small Intestinal Bacterial Overgrowth
An observational study of Small Intestinal Bacterial Overgrowth, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects attending the digestive (internal) Department and physical examination department/physical examination center of each center.
Who may be able to join
- Age 18-65 years old and gender;
- Patients with functional gastrointestinal disease are characterized by abdominal symptoms (abdominal distension, early satiety, diarrhea, constipation, abdominal pain, etc.)
- have the autonomy to complete methane and hydrogen breath testing and gastrointestinal symptom scoring independently or with medical assistance;
- able to complete the signing of informed consent as required.
- Age 18-65 years old and gender;
- Healthy individuals without obvious typical gastrointestinal symptoms;
- Autonomy to complete methane and hydrogen breath testing and gastrointestinal symptom scoring independently or with medical assistance;
- Ability to complete the informed consent form as required.
Who cannot join
- Patients whose gastroenteroscopy within one year indicated malignant tumor of digestive tract, or whose above examination proved peptic ulcer within two months;
- A history of malignant tumors of the digestive system (not limited to the digestive tract), a history of inflammatory bowel disease, or a history of false or mechanical ileus;
- Gastrointestinal resection, appendectomy and cholecystectomy within one year;
- History of gastrointestinal perforation, gastrointestinal bleeding, cholangitis, acute and chronic pancreatitis within one year;
- There is evidence of gastrointestinal tract infection (Helicobacter pylori, acute infectious enteritis);
- History of type I diabetes and primary hypothyroidism;
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- Confirmed lactose malabsorption, lactose intolerance, and pancreatic exocrine insufficiency;
- Within 4 weeks, a history of antibiotic administration;
- Within 2 weeks, history of endoscopy;
- Within 1 week, history of taking gastrointestinal stimulants, probiotics, laxatives;
- 1 day prior to testing, eating fermentable foods (yogurt, kimchi, soy sauce, tempeh, oats, beer, etc.);
- Not fasting 8 hours prior to testing;
- Smoking, strenuous exercise 2 hours before and during the test;
- Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.
Read the detailed description
Small intestinal bacterial overgrowth (SIBO) refers to a syndrome of gastrointestinal symptoms caused by changes in the number and/or type of bacteria in the small intestine, and is considered to be secondary to changes in intestinal anatomy, slowing of intestinal motility, or abnormalities in gastrointestinal function. Clinical symptoms of SIBO are atypical, and are mainly characterized by bloating, belching, abdominal pain, diarrhea, constipation, and changes in stool shape, color, odor, and other characteristics. Since the clinical symptoms of SIBO are not specific and the clinical diagnosis criteria are not standardized, its treatment has not been given enough attention.
- Conditions
- Small Intestinal Bacterial Overgrowth
- Keywords
- Small intestinal bacterial overgrowth, Methane and hydrogen breath test, Cut-off
What is being measured
The primary outcome is the main question the study is designed to answer.
Methane and hydrogen breath test results of experimental and control groups
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.
Measured: July 1, 2024 to December 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 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 Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, First Affiliated Hospital of Kunming Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jing-yuan Fang, MD,Ph.D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483360
- Sponsor's protocol ID
- LY2024-109-B
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2024
- Last updated
- 27 Aug 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methane and Hydrogen Breath Test for the Diagnosis of Small Intestinal Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT06483360
- Acronym / sponsor ID
- LY2024-109-B
- Conditions
- Small Intestinal Bacterial Overgrowth
- Keywords
- Small intestinal bacterial overgrowth, Methane and hydrogen breath test, Cut-off
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, First Affiliated Hospital of Kunming Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 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.
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.
Detailed description
Small intestinal bacterial overgrowth (SIBO) refers to a syndrome of gastrointestinal symptoms caused by changes in the number and/or type of bacteria in the small intestine, and is considered to be secondary to changes in intestinal anatomy, slowing of intestinal motility, or abnormalities in gastrointestinal function. Clinical symptoms of SIBO are atypical, and are mainly characterized by bloating, belching, abdominal pain, diarrhea, constipation, and changes in stool shape, color, odor, and other characteristics. Since the clinical symptoms of SIBO are not specific and the clinical diagnosis criteria are not standardized, its treatment has not been given enough attention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects attending the digestive (internal) Department and physical examination department/physical examination center of each center.
Key inclusion criteria (8 listed)
- Age 18-65 years old and gender;
- Patients with functional gastrointestinal disease are characterized by abdominal symptoms (abdominal distension, early satiety, diarrhea, constipation, abdominal pain, etc.)
- have the autonomy to complete methane and hydrogen breath testing and gastrointestinal symptom scoring independently or with medical assistance;
- able to complete the signing of informed consent as required.
- Age 18-65 years old and gender;
Key exclusion criteria (14 listed)
- Patients whose gastroenteroscopy within one year indicated malignant tumor of digestive tract, or whose above examination proved peptic ulcer within two months;
- A history of malignant tumors of the digestive system (not limited to the digestive tract), a history of inflammatory bowel disease, or a history of false or mechanical ileus;
- Gastrointestinal resection, appendectomy and cholecystectomy within one year;
- History of gastrointestinal perforation, gastrointestinal bleeding, cholangitis, acute and chronic pancreatitis within one year;
- There is evidence of gastrointestinal tract infection (Helicobacter pylori, acute infectious enteritis);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Methane and hydrogen breath test results of experimental and control groups
Time frame: July 1, 2024 to December 31, 2024
To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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-yuan Fang, MD,Ph.D principal investigator
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestinal Bacterial Overgrowth, run by Shanghai Jiao Tong University School of Medicine.
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 8 inclusion and 14 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 27 Aug 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-yuan Fang, MD,Ph.D (13046678061, fangjingyuan_new@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methane and hydrogen breath test results of experimental and control groups (time frame: July 1, 2024 to December 31, 2024). 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 27 Aug 2024.