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

NCT06483360 | Not Yet Recruiting

• 1 other identifier: LY2024-109-B
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Small Intestinal Bacterial Overgrowth

Keywords

Small intestinal bacterial overgrowth; Methane and hydrogen breath test; Cut-off

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

The body exhales air

Study Officials

• Jing-yuan Fang, MD,Ph.D

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-yuan Fang, MD,Ph.D

CONTACT

13046678061; fangjingyuan_new@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor, Vice president

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08