Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT03141268
Brief Summary:
Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen breath test for orocecal transit time through the gut. Data are compared to those of healthy volunteers. The peak value of fermentation as read by hydrogen levels is captured after passage of the orocecal segment in the colon. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.
Detailed Description:
Patients with IBS of various kind (constipation-dominant, diarrhea-dominant, and mixed form) in large numbers are studied as regards orocecal transit time and compared to healthy controls.
Inclusion criteria: IBS patients 18-80 years old, diagnosis of IBS; exclusion: Severe cardiac, pulmonary, liver or kidney disease, bloody stool After fasting for 12 hours, all subjects ingest 10 grams of lactulose. Hydrogen production, measured as hydrogen concentration in breath, is estimated at 10-minute intervals for a period of 240 minutes. The orocecal transit transit time is measured from ingestion of the lactulose solution until hydrogen peaks to 10 and 20 ppm when passing the ileocecal valve, being fermented by the cecal microflora. Data are compared to those of healthy volunteers.
The peak value of fermentation as read by hydrogen levels (ppm) captured after passage of the ilecocecal valve orocecal valve signifies the gas production of the micro13flora. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.
Study:
NCT03141268
Study Brief:
Protocol Section:
NCT03141268