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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Small Intestinal Bacterial Overgrowth

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 Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Jing-yuan Fang, MD,Ph.D; Phone Number: 13046678061; Email: fangjingyuan_new@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects attending the digestive (internal) Department and physical examination department/physical examination center of each center.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	July 1, 2024 to December 31, 2024

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Kunming Medical University
• Investigators: Principal Investigator: Jing-yuan Fang, MD,Ph.D, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Small intestinal bacterial overgrowth; Methane and hydrogen breath test; Cut-off
• Other Study ID Numbers: LY2024-109-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No