Irritable Bowel SyndromeNCT01674088
Sucrose Breath Test to Determine Intestinal Permeability in IBS
An observational study of Irritable Bowel Syndrome, run by Metabolic Solutions Inc. at 1 site in United States.
Trial summary
Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of the disease still remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinics of Shands Hospital, Gainesville, FL, residents within Gainesville, FL and students of the University of Florida.
Who may be able to join
- Male or females with clinical diagnosis of Irritable Bowel Syndrome by Rome III criteria (IBS Group) or healthy control.
- Must be 18 years old or greater.
- Women of child-bearing potential must have a negative pregnancy test.
Who cannot join
- Females who are lactating or pregnant.
- Subjects with allergy to sucrose.
- Subjects with other causes of abdominal pain or altered bowel habits such as IBD, celiac disease, pancreatitis or gastrointestinal bleeding.
- Subjects with a history of diabetes mellitus.
- Subjects with a recent febrile illness (5 days prior to study).
- Subjects that received an investigational drug or device within 30 days prior to study entry.
- Subjects that do not have the mental capacity to understand the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Shands Hospital
Gainesville, Florida, 32610
About this study
Official title: The Use of a Novel 13C Sucrose Breath Test (13C SBT) to Determine Intestinal Permeability in Irritable Bowel Syndrome (IBS) Patients
Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of the disease still remains unclear. It has been hypothesized that patients with IBS have alterations in the intestinal lining leading to release of toxic substances into the blood, commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive and invasive. The investigators will test a new breath test to measure leaky gut in both IBS patients and subjects without IBS symptoms.
Read the detailed description
The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects meet eligibility criteria, a single breath test will be conducted on all subjects. The breath test involves collecting breath by exhaling through a straw into a special test tube. A breath sample is collected before administration of sucrose. After the baseline breath sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the protocol is finished. We will be analyzing breath carbon dioxide for different levels of heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer. Our study plan is to compare the amount of carbon-13 in breath between IBS patients and subjects without the condition. Up to 20 subjects per group will be studied.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, breath testing, carbon-13
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome | Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome | |
| Healthy Controls | Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose
AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabolic Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- David A Wagner, PhD, Principal investigator, Metabolic Solutions Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674088
- Sponsor's protocol ID
- SBT-01
- Status last verified
- Feb 2014
- First submitted
- 23 Aug 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Novel 13C Sucrose Breath Test (13C SBT) to Determine Intestinal Permeability in Irritable Bowel Syndrome (IBS) Patients
- ClinicalTrials.gov ID
- NCT01674088
- Acronym / sponsor ID
- SBT-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, breath testing, carbon-13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Metabolic Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Aug 2012 (estimated)
- 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.
Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of the disease still remains unclear. It has been hypothesized that patients with IBS have alterations in the intestinal lining leading to release of toxic substances into the blood, commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive and invasive. The investigators will test a new breath test to measure leaky gut in both IBS patients and subjects without IBS symptoms.
Detailed description
The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects meet eligibility criteria, a single breath test will be conducted on all subjects. The breath test involves collecting breath by exhaling through a straw into a special test tube. A breath sample is collected before administration of sucrose. After the baseline breath sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the protocol is finished. We will be analyzing breath carbon dioxide for different levels of heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer. Our study plan is to compare the amount of carbon-13 in breath between IBS patients and subjects without the condition. Up to 20 subjects per group will be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Syndrome | – | –Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome |
| Healthy Controls | – | –Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics of Shands Hospital, Gainesville, FL, residents within Gainesville, FL and students of the University of Florida.
Key inclusion criteria (3 listed)
- Male or females with clinical diagnosis of Irritable Bowel Syndrome by Rome III criteria (IBS Group) or healthy control.
- Must be 18 years old or greater.
- Women of child-bearing potential must have a negative pregnancy test.
Key exclusion criteria (7 listed)
- Females who are lactating or pregnant.
- Subjects with allergy to sucrose.
- Subjects with other causes of abdominal pain or altered bowel habits such as IBD, celiac disease, pancreatitis or gastrointestinal bleeding.
- Subjects with a history of diabetes mellitus.
- Subjects with a recent febrile illness (5 days prior to study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose
Time frame: 90 minutes
AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
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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.
David A Wagner, PhD principal investigator
Metabolic Solutions Inc.
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 Irritable Bowel Syndrome, run by Metabolic Solutions Inc. at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Feb 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose (time frame: 90 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 10 Feb 2014.