Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06483360

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Methane and hydrogen breath test results of experimental and control groups

    Time frame: July 1, 2024 to December 31, 2024

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-yuan Fang, MD,Ph.D

CONTACT

[email protected]

13046678061

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • First Affiliated Hospital of Kunming Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • West China Hospital

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.