Oro-cecal Transit TimeRapidoIBSNCT03141268
Rapid Orocecal Transit Time and Fermentation in IBS.
An observational study of Oro-cecal Transit Time, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oro-cecal Transit Time
- What is being tested?
- Lactulose breath test
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.
Who cannot join
- Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, Uppsala County, 75185
Per M Hellstrom, MD, Prof, +46 70 3727423, Per.Hellstrom@medsci.uu.se
Dominic-Luc Webb, PhD, +46 18 4714721, Dominic-Luc.Webb@medsci.uu.se
About this study
Official title: Orocecal Transit Time and Fermentation in IBS
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.
Read the 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.
- Conditions
- Oro-cecal Transit Time
- Being tested
- Lactulose breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose breath testDiagnostic test
Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Normal subjects aged 18-80 years. No chronic diseases. Receives: Diagnostic Test: Lactulose breath test | |
| IBS patients, lactose intolerant | Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases. Receives: Diagnostic Test: Lactulose breath test | |
| IBS patients, lactose tolerant | Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases. Receives: Diagnostic Test: Lactulose breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orocecal transit time
The transit rate of lactulose (foods) through the small intestine
Measured: 0-240 minutes
Secondary outcomes (1)
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.
Measured: 0-240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oro-cecal Transit TimeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hellström, Uppsala University
- Investigators
- Per M Hellstrom, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141268
- Sponsor's protocol ID
- Orocecal lactulose breath
- Acronym
- RapidoIBS
- Status last verified
- Aug 2018
- First submitted
- 3 Apr 2017
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are freely available to anyone. Data coded.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orocecal Transit Time and Fermentation in IBS
- ClinicalTrials.gov ID
- NCT03141268
- Acronym / sponsor ID
- RapidoIBS / Orocecal lactulose breath
- Conditions
- Oro-cecal Transit Time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Lactulose breath testNormal subjects aged 18-80 years. No chronic diseases. |
| IBS patients, lactose intolerant | – | Diagnostic Test: Lactulose breath testSubjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases. |
| IBS patients, lactose tolerant | – | Diagnostic Test: Lactulose breath testSubjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.
Key exclusion criteria (1 listed)
- Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose breath testLactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality. | Diagnostic test | Healthy volunteers, IBS patients, lactose intolerant, IBS patients, lactose tolerant |
Primary outcome
Orocecal transit time
Time frame: 0-240 minutes
The transit rate of lactulose (foods) through the small intestine
1 secondary outcome
Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.
Time frame: 0-240 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: Yes. Data are freely available to anyone. Data coded.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per M Hellstrom, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oro-cecal Transit Time, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per M Hellstrom, MD, PhD (+46703727423, Per.Hellstrom@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orocecal transit time (time frame: 0-240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.