Status:
NOT_YET_RECRUITING
Methane and Hydrogen Breath Test for the Diagnosis of Small Intestinal Bacterial Overgrowth
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Conditions:
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-65 years
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- Inclusion criteria for the experimental group:
- 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.
- Inclusion criteria for the control group:
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06483360
Start Date
September 1 2024
End Date
December 31 2025
Last Update
August 27 2024
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