small intestinal bacterial overgrowth
Conditions
Interventions
Urea(13C) and Lactulose administration
Sponsors
Isomoto Hajime
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Individuals aged 18 years or older at the time of obtaining informed consent. (2) Patients presenting with abdominal bloating, abdominal pain, flatulence, belching, abdominal discomfort, or chronic diarrhea/constipation persisting for at least three months, or those diagnosed with gastroesophageal reflux disease, functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease, chronic liver disease, or liver cirrhosis. (3) Individuals with no evidence of Helicobacter pylori infection. (4) Among patients with abdominal symptoms persisting for at least three months, those in whom the cause of abdominal symptoms remains unexplained based on previous computed CT and upper gastrointestinal endoscopy findings. (5) Individuals who are scheduled to undergo upper gastrointestinal endoscopy as part of their routine clinical care.
Exclusion criteria
Exclusion criteria: (1) Individuals with galactosemia. (2) Individuals who have taken antibiotics or alpha-glucosidase inhibitors within the past four weeks. (3) Individuals who have taken following drugs within the past one week: probiotics, gastrointestinal motility inhibitors including opioids, anticholinergics, and GLP-1 receptor agonists, acid-suppressing agents including proton pump inhibitors, potassium-competitive acid blockers, and H receptor antagonists, and NSAIDs. (4) Individuals who require glucagon administration during endoscopic examination. (5) Patients with poorly controlled diabetes mellitus, in whom marked hyperglycemia is expected following ingestion of 10 g of lactulose. (6) Individuals who have received investigational drugs or study medications within the three months prior to study enrollment. (7) Pregnant women or those with the possibility of being pregnant. (8) Breastfeeding women. (9) Individuals with organic gastrointestinal diseases including tumors, active ulcerative lesions, or severe stenosis and obstruction. (10) Individuals who are deemed inappropriate for participation by the principal investigator or subinvestigators. (11) Individuals with a history of gastrointestinal surgery in the esophagus, stomach, duodenum, small intestine, or colon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum 13C change from 0 to 90 minutes by urea breath test between the two groups of SIBO and non-SIBO | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)When a significant 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) (7) Prevalence of small intestinal bacterial overgrowth (SIBO) in gastroesophageal reflux disease, functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease, chronic liver disease, and liver cirrhosis. (8) Clinical and laboratory characteristics of SIBO-complicated cases of gastroesophageal reflux disease, functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease, chronic liver disease, and liver cirrhosis. | — |
Contacts
Public ContactRyohei Ogihara
Tottori University Hospital
Outcome results
None listed