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Rapid Orocecal Transit Time and Fermentation in IBS.

Orocecal Transit Time and Fermentation in IBS

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03141268
Acronym
RapidoIBS
Enrollment
1000
Registered
2017-05-05
Start date
2017-01-01
Completion date
2019-07-01
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oro-cecal Transit Time

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.

Interventions

DIAGNOSTIC_TESTLactulose breath test

Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Orocecal transit time0-240 minutesThe transit rate of lactulose (foods) through the small intestine

Secondary

MeasureTime frameDescription
Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.0-240 minutesThe rise of hydrogen (beyond 10 and 20 ppm) after lactulose passing the ileo-cecal valve.

Countries

Sweden

Contacts

Primary ContactPer M Hellstrom, MD, PhD
Per.Hellstrom@medsci.uu.se+46703727423
Backup ContactPeter Benno, MD, PhD
Peter.Benno@endoskopienheten.se+46705795554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026