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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04910815




Registration number
NCT04910815
Ethics application status
Date submitted
26/05/2021
Date registered
2/06/2021

Titles & IDs
Public title
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Scientific title
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Secondary ID [1] 0 0
72853
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Intestinal Bacterial Overgrowth 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Diagnosis / Prognosis
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Structured Assessment of Gastro-Intestinal Symptoms
Timepoint [1] 0 0
30 minutes prior to endoscopy
Primary outcome [2] 0 0
Hydrogen fermentation in the small intestine as measured by the Atmo capsule
Timepoint [2] 0 0
30 minutes prior to endoscopy
Primary outcome [3] 0 0
Small Intestine microbial load as assessed by Jejunal Aspiration and Culture
Timepoint [3] 0 0
During endoscpoic procedure
Secondary outcome [1] 0 0
FOS Breath samples on the day of the endoscopy
Timepoint [1] 0 0
Up to 2 hours after the endescopic procedure
Secondary outcome [2] 0 0
Glucose Breath Test
Timepoint [2] 0 0
Not earlier than 12 hours after the endoscopic procedure

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Uttar Pradesh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atmo Biosciences Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Gerald Holtman, MD, PhD, MBA
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Teressa Hansen, PhD
Address 0 0
Country 0 0
Phone 0 0
07 3176 9190
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04910815