Breath test with small intestinal bacterial overgrowth

JRCT ID: jRCTs061230012

Registered date:12/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: small intestinal bacterial overgrowth
• Date of first enrollment: 12/05/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Urea(13C) and Lactulose administration

Outcome(s)

• Primary Outcome: Maximum 13C change from 0 to 90 minutes by urea breath test between the two groups of SIBO and non-SIBO

Secondary Outcome

(1)When a superiority difference is observed in the primary endpoint, calculate the cut off value, its sensitivity, specificity, positive predictive value, and negative predictive value.
(2)the maximum value of delta13C from 0 to 90 minutes by urea breath test between the SIBO and non-SIBO by comorbidities
(3)metabolomic analysis in exhaled breath condensate
(4) intestinal microbiota analysis using feces
(5)evaluation of intestinal permeability
(6) safty (adverse event, side effect, vital sign)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)18 or above years old male or female
(2)Patients with symptoms such as abdominal distention, abdominal pain, flatulence, burping, abdominal discomfort, chronic diarrhea/constipation lasting more than 3 months
(3) Patients who are not infected with H. Pylori
(4)Patients whose abdominal symptoms have not been identified by previous CT scan or upper gastrointestinal endoscopy.
(5) Patients who are scheduled to undergo upper gastrointestinal endoscopy as a routine medical examination

Exclude criteria

(1)Patients who have galactosemia
(2)Patients who have taken antibiotics within 1 month
(3)Patientswho have taken an intestinal antiflatulent, intestinal peristaltic, or PPI within 1 week
(4)Patients requiring the use of glucagon for endoscopy
(5)Diabetics with poorly controlled blood glucose (Hyperglycemia is expected after taking 10 g of lactulose)
(6)Patients taking oral alpha-glucosidase inhibitors
(7)Patients who have received other research or investigational drugs within 3 months prior to the start of treatment
(8)Pregnant women or patients who may be pregnant
(9)Patients who are breast-feeding
(10)Patients with organic disease (tumor, acute ulcerative lesion, severe stenosis or obstruction, etc.)
(11)Patients deemed inappropriate by the principal investigator and research staff

Related Information

• Primary Sponsor: Isomoto Hajime