Clinical trial NCT03141268: Rapid Orocecal Transit Time and Fermentation in IBS.
Official title: Orocecal Transit Time and Fermentation in IBS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oro-cecal Transit Time
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBS patients aged 18-80 years of age as recruited in the clinic, some of which are lactose intolerant, others are lactose tolerant.

Healthy volunteers 18-80 years of age as recruited in society in daily life activities.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Orocecal transit time
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.
timeFrame: 0-240 minutes
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
state: Uppsala County
Study officials:
affiliation: Uppsala University
name: Per M Hellstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: