Small Intestinal Bacterial OvergrowthNCT04499742
Comparative Assessment of Radioisotope Glucose and Breath Test
An observational study of Small Intestinal Bacterial Overgrowth, run by Augusta University at 1 site in United States.
Trial summary
This is a research study about improving our diagnostic method for small intestinal bacterial overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth
- What is being tested?
- Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 14 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients exhibiting SIBO symptoms.
Who may be able to join
- Patients with recent gas, bloating, distension, and suspected SIBO
- Negative oral GBT
- 18 years and older
Who cannot join
- Pregnancy
- Diabetes
- Previous abdominal surgery except cholecystectomy, appendectomy
- Diet prep non-adherence
- Smoking or exercise causing hyperventilation prior to exam
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University Digestive Health Research
Augusta, Georgia, 30912
Tennekoon Karunaratne, MD, PhD, 706-721-1968, tkarunaratne@augusta.edu
Audrey Eubanks, BS, 7067211968, aueubanks@augusta.edu
About this study
Official title: Does Rise in Breath Hydrogen During Endoscopically Assisted Glucose Breath Test (EAGBT) Correlate With Radio-Isotope Location in Small Bowel: Improving Detection of Distal SIBO
This is a research study about improving our diagnostic method for small intestinal bacterial overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study, investigators wish to utilize Nuclear Medicine techniques to locate where the glucose solution that is administered during EAGBT is being consumed by bacteria is in the small bowel when it detects SIBO.
Read the detailed description
Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention, and diarrhea due to colonization and an excessive amount of bacteria in the small bowel. Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion, the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum. Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses distal SIBO.
Investigators have recently shown that glucose administration into the distal duodenum through upper endoscopy has a higher positive yield for SIBO in patients with negative oral GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the colon, i.e. false-positive test. Study objective here is to administer a radio-labeled glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then determine if the rise in breath hydrogen and/or methane correlates with the location of the isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy. Clinical response to treatment will be assessed on follow up.
- Conditions
- Small Intestinal Bacterial Overgrowth
- Being tested
- Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.Radiation
Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between GBT result and isotope detection in small bowel
Overall correlation (positive and negative) between the location of glucose isotope in small bowel (imaging) and changes in in hydrogen and methane values obtained during the breath test.
Measured: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Secondary outcomes (3)
Diagnostic yield of EAGBT compared to oral GBT
We will compare the yield (positive, negative and overall) of endoscopic assisted GBT versus orally administered GBT
Measured: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Diagnostic yield of EAGBT compared to duodenal aspirate and culture
We will compare the positive and negative yield of EAGBT with the positive (>1000 CFU/ml) or negative yield of aerobic and anaerobic cultures.
Measured: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Symptom patterns and demographics
Compare the gas and bloating symptom patterns, clinical characteristics predisposing factors including underlying dysmotility and other demographic features between patients with positive and negative EAGBT and cultures.
Measured: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start21 Jan 2019
- Primary completion14 Dec 2021 (estimated)
- Study completion14 Dec 2021 (estimated)
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-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
- Investigators
- Satish Rao, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499742
- Sponsor's protocol ID
- 1328690
- Status last verified
- Aug 2020
- First submitted
- 19 Feb 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Rise in Breath Hydrogen During Endoscopically Assisted Glucose Breath Test (EAGBT) Correlate With Radio-Isotope Location in Small Bowel: Improving Detection of Distal SIBO
- ClinicalTrials.gov ID
- NCT04499742
- Acronym / sponsor ID
- 1328690
- Conditions
- Small Intestinal Bacterial Overgrowth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 14 Dec 2021 (estimated)
- Study completion
- 14 Dec 2021 (estimated)
- First posted
- 5 Aug 2020 (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.
This is a research study about improving our diagnostic method for small intestinal bacterial overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study, investigators wish to utilize Nuclear Medicine techniques to locate where the glucose solution that is administered during EAGBT is being consumed by bacteria is in the small bowel when it detects SIBO.
Detailed description
Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention, and diarrhea due to colonization and an excessive amount of bacteria in the small bowel. Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion, the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum. Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses distal SIBO.
Investigators have recently shown that glucose administration into the distal duodenum through upper endoscopy has a higher positive yield for SIBO in patients with negative oral GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the colon, i.e. false-positive test. Study objective here is to administer a radio-labeled glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then determine if the rise in breath hydrogen and/or methane correlates with the location of the isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy. Clinical response to treatment will be assessed on follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients exhibiting SIBO symptoms.
Key inclusion criteria (3 listed)
- Patients with recent gas, bloating, distension, and suspected SIBO
- Negative oral GBT
- 18 years and older
Key exclusion criteria (5 listed)
- Pregnancy
- Diabetes
- Previous abdominal surgery except cholecystectomy, appendectomy
- Diet prep non-adherence
- Smoking or exercise causing hyperventilation prior to exam
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 |
|---|---|---|
| Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut. | Radiation | – |
Primary outcome
Correlation between GBT result and isotope detection in small bowel
Time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Overall correlation (positive and negative) between the location of glucose isotope in small bowel (imaging) and changes in in hydrogen and methane values obtained during the breath test.
3 secondary outcomes
Diagnostic yield of EAGBT compared to oral GBT
Time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Diagnostic yield of EAGBT compared to duodenal aspirate and culture
Time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Symptom patterns and demographics
Time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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 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, 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 3 inclusion and 5 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 5 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tennekoon Karunaratne, MD, PhD (7067211968, tkarunaratne@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between GBT result and isotope detection in small bowel (time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)). 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 5 Aug 2020.