Small Intestinal Bacterial OvergrowthNCT03261856
Clinical Utility of Breath Tests in GI
An observational study of Small Intestinal Bacterial Overgrowth and Lactose Intolerance, run by Augusta University at 1 site in United States.
Trial summary
Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative; these patients are labeled as IBS. In these patients, whether testing for carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Lactose Intolerance, Fructose Intolerance
- How many people
- 1,080 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2011to 31 Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had breath tests as part of routine standard of care to diagnose the unexplained GI symptoms that were abnormal results.
Who may be able to join
- Patients over the age of 18
- Unexplained GI symptoms (gas, bloating, diarrhea, fullness, belching, and abdominal pain)
- Patients who have had normal blood tests and colonoscopy, normal CT or ultrasound scan of the abdomen
- Patients who have completed at least one breath test
Who cannot join
- Patients with previous GI surgeries (except cholecystectomy, hysterectomy, Nissen funduplication and appendectomy)
- Significant comorbid medical problems (congestive heart failure, chronic renal failure, respiratory failure)
- Cancer
- History of recent antibiotic use (4 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of Carbohydrate Breath Tests in Unexplained GI Symptoms
Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative; these patients are labeled as IBS. In these patients, whether testing for carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath tests, and predictive value of pre-test symptoms.
Read the detailed description
Abdominal bloating, gas, belching, distension, and diarrhea are common gastrointestinal symptoms that are reported by at least 1/3rd of patients presenting to gastroenterology clinics. When routine endoscopic and radiological tests are negative1, most of these patients are labeled as irritable bowel syndrome (IBS) in gastroenterology practice2. Unfortunately these symptoms persist and these patients remain dissatisfied with their health care and continue to doctor shops or seek remedies from alternative care. Several studies have shown that these symptoms have a significant and negative impact on their quality of life. One possible explanation for their symptom is carbohydrate food intolerance. The Western diet has changed significantly over the last 3 decades. Today, large amounts of fructose are being consumed. This sugar is used as a sweetener in sodas, fruit juices, multiples beverages and candies. Although is naturally present in apples, peaches, pears and oranges, the exponential products and consumption of the synthetic high fructose corn syrup has alarmingly increased fructose consumption. When small amounts are ingested, fructose is completely absorbed from the gut mainly through Glut 5transporter from the intestinal brush border or through facilitated transport along glucose through the Glut 2 transporter5. If a person has either limited absorptive capacity or overwhelms normal absorption capacity by excess ingestion, then malabsorption of fructose ensues. This unabsorbed fructose can serve, as an osmotic load, that draws fluid into the intestinal lumen, causing abdominal bloating, gas, pain and diarrhea 6-7. Likewise lactose is a disaccharide that is present in dairy products and is widely consumed. After ingestion lactose is hydrolyzed in the small intestine by the brush border enzyme lactase into glucose and galactose that are in torn absorbed8. If lactose is malabsorbed by Glut 2, then it will serve as an osmotic load, and get rapidly propelled in to the colon where it is fermented by the colonic bacterial flora, into short chain fatty acid, hydrogen,methane and other gases, this lactose malabsorption produces gas, bloating, flatulence and diarrhea9. About 75% of the world´s population gradually lose their ability to produce the lactase enzyme after age 30 years10-11.
Malabsorption or intolerance of carbohydrates such as fructose and lactose are common and frequently encountered both in the primary care and specialist gastroenterology clinics, but are poorly recognized or treated. Over the last decade, breath testing has emerged as a simple, non invasive method of identifying malabsorption and/ or intolerance to common food ingredients such as fructose12, and lactose13, as well as to identify small intestinal bacterial overgrowth (SIBO)14. However, they are only performed in selected academic centers, and their clinical utility and diagnostic yield largely remains unknown.
Also may the clinical utility of performing a single breath test versus a cumulative battery of breath tests, such as glucose, lactose or fructose breath test, in a patient with unexplained GI symptoms is also not known.
The aims of this study are to investigate a consecutive series of patients with unexplained chronic GI symptoms and examine; 1) the prevalence of SIBO answered by the glucose breath test, fructose and lactose intolerance answered by the fructose y lactose breath test, ; 2) the predictive value of pre-test symptoms in the diagnosis of SIBO or carbohydrate intolerance.
- Conditions
- Small Intestinal Bacterial Overgrowth, Lactose Intolerance, Fructose Intolerance, Glucose Intolerance
- Keywords
- Breath test, SIBO, GI
- Medical subject headings
- Lactose Intolerance, Fructose Intolerance, Glucose Intolerance
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 |
|---|---|---|
| small intetsinal bacterial overgrowth | Glucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours | |
| Fructose breath Test | Fructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours | |
| Lactose Breath test | Lactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small Intestinal Bacterial Overgrowth
bacterial overgrowth which results in the inability to absorb nutrients
Measured: 3 hour test
Positive Breath test
significant increase in the level of Hydrogen greater than or equal to 20ppm or methane greater than or equal to 15ppm or both above greater than or equal to 15ppm baseline.
Measured: 3 hour test
Malabsorption
significant rise in hydrogen and/or methane levels
Measured: 3 hour test
Intolerance
both the presence of malabsorption and the onset of new symptom or an increase (greater than or equal to 1) in the severity of baseline symptoms
Measured: 3 hour test
Normal test
absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.
Measured: 3 hour test
hypersensitivity
significant increase (greater than or equal to 1) in the severity of two or more baseline symptoms together with no significant rise in hydrogen or methane levels
Measured: 3 hour test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start31 Aug 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satish SC Rao, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261856
- Sponsor's protocol ID
- 1114725
- Status last verified
- Jul 2018
- First submitted
- 23 Aug 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Carbohydrate Breath Tests in Unexplained GI Symptoms
- ClinicalTrials.gov ID
- NCT03261856
- Acronym / sponsor ID
- 1114725
- Conditions
- Small Intestinal Bacterial Overgrowth, Lactose Intolerance, Fructose Intolerance, Glucose Intolerance
- Keywords
- Breath test, SIBO, GI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 31 Aug 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Aug 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.
Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative; these patients are labeled as IBS. In these patients, whether testing for carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath tests, and predictive value of pre-test symptoms.
Detailed description
Abdominal bloating, gas, belching, distension, and diarrhea are common gastrointestinal symptoms that are reported by at least 1/3rd of patients presenting to gastroenterology clinics. When routine endoscopic and radiological tests are negative1, most of these patients are labeled as irritable bowel syndrome (IBS) in gastroenterology practice2. Unfortunately these symptoms persist and these patients remain dissatisfied with their health care and continue to doctor shops or seek remedies from alternative care. Several studies have shown that these symptoms have a significant and negative impact on their quality of life. One possible explanation for their symptom is carbohydrate food intolerance. The Western diet has changed significantly over the last 3 decades. Today, large amounts of fructose are being consumed. This sugar is used as a sweetener in sodas, fruit juices, multiples beverages and candies. Although is naturally present in apples, peaches, pears and oranges, the exponential products and consumption of the synthetic high fructose corn syrup has alarmingly increased fructose consumption. When small amounts are ingested, fructose is completely absorbed from the gut mainly through Glut 5transporter from the intestinal brush border or through facilitated transport along glucose through the Glut 2 transporter5. If a person has either limited absorptive capacity or overwhelms normal absorption capacity by excess ingestion, then malabsorption of fructose ensues. This unabsorbed fructose can serve, as an osmotic load, that draws fluid into the intestinal lumen, causing abdominal bloating, gas, pain and diarrhea 6-7. Likewise lactose is a disaccharide that is present in dairy products and is widely consumed. After ingestion lactose is hydrolyzed in the small intestine by the brush border enzyme lactase into glucose and galactose that are in torn absorbed8. If lactose is malabsorbed by Glut 2, then it will serve as an osmotic load, and get rapidly propelled in to the colon where it is fermented by the colonic bacterial flora, into short chain fatty acid, hydrogen,methane and other gases, this lactose malabsorption produces gas, bloating, flatulence and diarrhea9. About 75% of the world´s population gradually lose their ability to produce the lactase enzyme after age 30 years10-11.
Malabsorption or intolerance of carbohydrates such as fructose and lactose are common and frequently encountered both in the primary care and specialist gastroenterology clinics, but are poorly recognized or treated. Over the last decade, breath testing has emerged as a simple, non invasive method of identifying malabsorption and/ or intolerance to common food ingredients such as fructose12, and lactose13, as well as to identify small intestinal bacterial overgrowth (SIBO)14. However, they are only performed in selected academic centers, and their clinical utility and diagnostic yield largely remains unknown.
Also may the clinical utility of performing a single breath test versus a cumulative battery of breath tests, such as glucose, lactose or fructose breath test, in a patient with unexplained GI symptoms is also not known.
The aims of this study are to investigate a consecutive series of patients with unexplained chronic GI symptoms and examine; 1) the prevalence of SIBO answered by the glucose breath test, fructose and lactose intolerance answered by the fructose y lactose breath test, ; 2) the predictive value of pre-test symptoms in the diagnosis of SIBO or carbohydrate intolerance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| small intetsinal bacterial overgrowth | – | –Glucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours |
| Fructose breath Test | – | –Fructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours |
| Lactose Breath test | – | –Lactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had breath tests as part of routine standard of care to diagnose the unexplained GI symptoms that were abnormal results.
Key inclusion criteria (4 listed)
- Patients over the age of 18
- Unexplained GI symptoms (gas, bloating, diarrhea, fullness, belching, and abdominal pain)
- Patients who have had normal blood tests and colonoscopy, normal CT or ultrasound scan of the abdomen
- Patients who have completed at least one breath test
Key exclusion criteria (4 listed)
- Patients with previous GI surgeries (except cholecystectomy, hysterectomy, Nissen funduplication and appendectomy)
- Significant comorbid medical problems (congestive heart failure, chronic renal failure, respiratory failure)
- Cancer
- History of recent antibiotic use (4 weeks)
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
Small Intestinal Bacterial Overgrowth
Time frame: 3 hour test
bacterial overgrowth which results in the inability to absorb nutrients
Positive Breath test
Time frame: 3 hour test
significant increase in the level of Hydrogen greater than or equal to 20ppm or methane greater than or equal to 15ppm or both above greater than or equal to 15ppm baseline.
Malabsorption
Time frame: 3 hour test
significant rise in hydrogen and/or methane levels
Intolerance
Time frame: 3 hour test
both the presence of malabsorption and the onset of new symptom or an increase (greater than or equal to 1) in the severity of baseline symptoms
Normal test
Time frame: 3 hour test
absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.
hypersensitivity
Time frame: 3 hour test
significant increase (greater than or equal to 1) in the severity of two or more baseline symptoms together with no significant rise in hydrogen or methane levels
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 17 Feb 2020.
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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.
Satish SC Rao, MD, PhD principal investigator
Augusta 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 Small Intestinal Bacterial Overgrowth and Lactose Intolerance, run by Augusta University 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 4 inclusion and 4 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 17 Feb 2020. 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?
Small Intestinal Bacterial Overgrowth (time frame: 3 hour test). The study lists 6 primary outcomes in all. 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 17 Feb 2020.