Methane and Hydrogen Breath Test for the Diagnosis of Small Intestinal Bacterial Overgrowth

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special test called the methane and hydrogen breath test to see if it can help diagnose a condition known as Small Intestinal Bacterial Overgrowth (SIBO). SIBO happens when there are too many bacteria in the small intestine, which can cause symptoms like bloating, stomach pain, diarrhea, or constipation. The study will compare the results of this breath test in two groups of people: those who have symptoms of gastrointestinal issues and healthy individuals without these symptoms.

To be eligible for the trial, participants should be between 18 and 65 years old. Those in the experimental group must have ongoing abdominal symptoms, while the control group should be healthy and not experiencing any gastrointestinal problems. Participants will be asked to complete the breath test, which measures gases produced by bacteria in the gut, and fill out a questionnaire about their symptoms. It's important to note that certain health conditions and recent medical treatments may exclude individuals from participating. If you're interested, this study is currently not recruiting yet, so you would need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Inclusion criteria for the experimental group:
• • 1. Age 18-65 years old and gender;
• • 2. Patients with functional gastrointestinal disease are characterized by abdominal symptoms (abdominal distension, early satiety, diarrhea, constipation, abdominal pain, etc.)
• • 3. have the autonomy to complete methane and hydrogen breath testing and gastrointestinal symptom scoring independently or with medical assistance;
• • 4. able to complete the signing of informed consent as required.
• Inclusion criteria for the control group:
• • 1. Age 18-65 years old and gender;
• • 2. Healthy individuals without obvious typical gastrointestinal symptoms;
• • 3. Autonomy to complete methane and hydrogen breath testing and gastrointestinal symptom scoring independently or with medical assistance;
• • 4. Ability to complete the informed consent form as required.
• Exclusion Criteria:
• • 1. Patients whose gastroenteroscopy within one year indicated malignant tumor of digestive tract, or whose above examination proved peptic ulcer within two months;
• • 2. 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;
• • 3. Gastrointestinal resection, appendectomy and cholecystectomy within one year;
• • 4. History of gastrointestinal perforation, gastrointestinal bleeding, cholangitis, acute and chronic pancreatitis within one year;
• • 5. There is evidence of gastrointestinal tract infection (Helicobacter pylori, acute infectious enteritis);
• • 6. History of type I diabetes and primary hypothyroidism;
• • 7. Confirmed lactose malabsorption, lactose intolerance, and pancreatic exocrine insufficiency;
• • 8. Within 4 weeks, a history of antibiotic administration;
• • 9. Within 2 weeks, history of endoscopy;
• • 10. Within 1 week, history of taking gastrointestinal stimulants, probiotics, laxatives;
• • 11. 1 day prior to testing, eating fermentable foods (yogurt, kimchi, soy sauce, tempeh, oats, beer, etc.);
• • 12. Not fasting 8 hours prior to testing;
• • 13. Smoking, strenuous exercise 2 hours before and during the test;
• • 14. Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded.