Rapid Orocecal Transit Time and Fermentation in IBS.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Orocecal Transit Time and Fermentation in IBS

Conditions
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Oro-cecal Transit Time

Intervention / Treatment
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* Diagnostic Test: Lactulose breath test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication. Exclusion Criteria: Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Normal subjects aged 18-80 years. No chronic diseases. | Diagnostic Test: Lactulose breath test<br>* Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.<br>|
| IBS patients, lactose intolerant<br>Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases. | Diagnostic Test: Lactulose breath test<br>* Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.<br>|
| IBS patients, lactose tolerant<br>Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases. | Diagnostic Test: Lactulose breath test<br>* Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orocecal transit time | The transit rate of lactulose (foods) through the small intestine | 0-240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath. | The rise of hydrogen (beyond 10 and 20 ppm) after lactulose passing the ileo-cecal valve. | 0-240 minutes |