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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04910815
Registration number
NCT04910815
Ethics application status
Date submitted
26/05/2021
Date registered
2/06/2021
Date last updated
30/01/2024
Titles & IDs
Public title
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
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Scientific title
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
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Secondary ID [1]
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72853
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Intestinal Bacterial Overgrowth
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Atmo Gas Capsule
Diagnosis / Prognosis - Glucose Breath Test
Diagnosis / Prognosis - Fructoolifosaccharides (FOS) Breath Test
Treatment: Surgery - Jejunal Aspiration and culture
Treatment: Drugs - Rifaximin
Treatment: Drugs - Placebo
Experimental: Primary recruitment - Capsules will be ingested within 30 minutes prior to endoscopy pre- and post-antimicrobial intervention (if the patients has had a treatment) to determine if it can be used to identify increased microbial load through gas detection, and to identify responders to therapy.
Active Comparator: Active SIBO Arm - Rifaximin - If increased microbial load is determined through culture of aspiration during initial endoscopic procedure, randomised administration of Rifaximin (550g) 1 capsule twice a day for 14 days. The post-antimicrobial endoscopic procedure will be conducted at 6 weeks post the start of treatment.
These hydrogen concentration results will be compared to the following conventional breath tests in a crossover study design. Immediately after the endoscopic procedure, the patient will undergo a FOS challenge recording hydrogen breath samples for 2 hours in 20 min intervals while they recover from the endoscopic procedure. A standard Glucose breath test will be performed by the patients at home not earlier that 8 hours after the endoscopic procedure.
Placebo Comparator: Active SIBO Arm - Placebo - If increased microbial load is determined through culture of aspiration during initial endoscopic procedure, randomised administration of placebo capsule twice a day for 14 days. The placebo will be encapsulated maize starch and pregelatinised maize starch. The post-antimicrobial endoscopic procedure will be conducted at 6 weeks post the start of treatment.
These hydrogen concentration results will be compared to the following conventional breath tests in a crossover study design. Immediately after the endoscopic procedure, the patient will undergo a FOS challenge recording hydrogen breath samples for 2 hours in 20 min intervals while they recover from the endoscopic procedure. A standard Glucose breath test will be performed by the patients at home not earlier that 8 hours after the endoscopic procedure.
Treatment: Devices: Atmo Gas Capsule
The Atmo gas capsule is an ingestible electronic device. This capsule consists of gas and temperature sensors, electronic circuits, radio transmitter and silver oxide batteries. It can measure the concentrations and types of intestinal gases in individuals and give an indication of gut transit time. This data is used for research purposes to gain an understanding of the microbiota's localised functionality. The data from the sensors is transmitted out of the body over the radio frequency to a handheld receiver. The capsule passes out of the human body at the end of the measurement and is disposable.
Diagnosis / Prognosis: Glucose Breath Test
Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
Diagnosis / Prognosis: Fructoolifosaccharides (FOS) Breath Test
FOS is a long chain carbohydrate that can only be broken down by bacteria with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
Treatment: Surgery: Jejunal Aspiration and culture
Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases
Treatment: Drugs: Rifaximin
Rifaximin (550g) 1 capsule twice a day for 14 days.
Treatment: Drugs: Placebo
randomised administration of either placebo or Rifaximin (550g) 1 capsule twice a day for 14 days. The placebo will be encapsulated maize starch and pregelatinised maize starch
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Diagnosis / Prognosis
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Intervention code [3]
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Treatment: Surgery
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Intervention code [4]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Structured Assessment of Gastro-Intestinal Symptoms
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Assessment method [1]
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22 item assessing gastrointestinal symptoms. Response items are on a 5-point scale from (1 )no problem to (5) very severe problem. This is given to patients attending the Department of Gastroenterology & Hepatology at Princess Alexandra Hospital as part of their routine clinical care.
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Timepoint [1]
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30 minutes prior to endoscopy
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Primary outcome [2]
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Hydrogen fermentation in the small intestine as measured by the Atmo capsule
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Assessment method [2]
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Approximately 30 minutes before the endoscopic procedure, participants will be asked to swallow the capsule (Atmo capsule), which is the size of a large vitamin pill. If the capsule still is in the stomach at the time of the procedure it will be endoscopically pushed into the small intestine. 5g of Fructooligosaccharide (FOS) in 25mL of water will be flushed via the working channel of the endoscope into the small intestine to ensure that carbohydrates are available for fermentation. Subsequently the capsule is propelled by the normal peristaltic waves through the whole gut and is excreted after several days with the faeces. During transit the capsule transmits data about the concentration of specific gases (e.g. hydrogen) in the gut to a small receiver outside of the body.
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Timepoint [2]
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30 minutes prior to endoscopy
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Primary outcome [3]
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Small Intestine microbial load as assessed by Jejunal Aspiration and Culture
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Assessment method [3]
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The density of the bacterial colonisation of mucosal biopsies obtained during endoscpoy will be used to determine the role of the bacterial density
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Timepoint [3]
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During endoscpoic procedure
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Secondary outcome [1]
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FOS Breath samples on the day of the endoscopy
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Assessment method [1]
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Immediately prior to the endoscopy a baseline breath sample (approximately 400 cc) will be collected. FOS will be administered into the duodenum during endoscopy. After completion of the endoscopic procedure additional samples will be taken every 20 minutes up to 2 hours after the procedure.
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Timepoint [1]
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Up to 2 hours after the endescopic procedure
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Secondary outcome [2]
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Glucose Breath Test
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Assessment method [2]
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The patients will be asked to perform (not earlier than at least 8 hours after the endoscopic procedure) at home a standard glucose test consistent with the established clinical protocol for the diagnosis of SIBO (see SOP for Hydrogen Breath Test for Small Intestinal Bacterial Overgrowth). For this test patients will drink 75 g of glucose and breath samples will be taken at baseline and every 20 minutes for 2 hrs.
Samples will be analysed for increased hydrogen, methane and carbon dioxide using a Breathtracker digital microlyser (Quintron Inc USA). If bacteria are present in the upper part of the small intestine, a rise in 12ppm of hydrogen over baseline is indicative of bacterial overgrowth.
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Timepoint [2]
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Not earlier than 12 hours after the endoscopic procedure
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Eligibility
Key inclusion criteria
Patients aged over 18 years presenting to the Department of Gastroenterology & Hepatology
at the Princess Alexandra Hospital who require and are booked for an upper gastrointestinal
endoscopy as part of the routine diagnostic work up of e.g. otherwise unexplained
gastrointestinal symptoms.
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Minimum age
18
Years
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Radiation Enteritis
- Pregnancy
- Gastric bezoar
- Swallowing disorders/dysphagia to food or pills
- Obese, with BMI over 35
- Suspected or known strictures of the GI tract
- Fistulas or physiological/mechanical GI obstruction
- GI surgery within the past 3 months
- Diverticultis
- Patients with implantable or portable electro-mechanical medical devices, e.g.
pacemakers
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Uttar Pradesh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Atmo Biosciences Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if the gas-sensing capsule can be used to identify
increased numbers and a change of the composition of microbiota or microorganisms in the gut
to assess small intestinal dysbiosis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04910815
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Professor Gerald Holtman, MD, PhD, MBA
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Address
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The University of Queensland
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Teressa Hansen, PhD
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Address
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Country
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Phone
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07 3176 9190
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04910815
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