Not Yet RecruitingNot Applicable

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

750 participantsStarted 2024-09-01

Plain-language summary

To investigate whether the positive rates of methane and hydrogen breath test were different between the experimental group and the control group.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Methane and hydrogen breath test results of experimental and control groups

Timeframe: July 1, 2024 to December 31, 2024

NCT IDNCT06483360

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Jing-yuan Fang, MD,Ph.D

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;