Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.

NCT ID: NCT04910815

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2024-08-01

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

Detailed Description

In order to diagnose an increased bacterial density in the small intestine (e.g small intestinal bacterial overgrowth) metabolic activity of the microbiota colonising the small intestine is measured by exposing these bacteria with readily fermentable carbohydrates and measure subsequently (e.g. for 2 hrs) the change of the concentration of hydrogen (H2) and/or methane in the exhaled breath that results from carbohydrate fermentation in the small intestine. This is the principle of existing breath hydrogen tests, but they are poor at distinguishing where in the intestine the H2 is being produced, and their sensitivity is diminished by 'noise' in the breath H2 as a consequence of hydrogen or methane producing bacteria in the colon and this is frequently observed in the routine clinical setting. These shortcomings can be theoretically overcome by using the Atmo Gas CapsuleR which measures after ingestion gas concentrations during gastrointestinal transit in the lumen of the gut. As a consequence at the site of fermentation parts per hundred can be measured, rather than the parts per million (ppm) when methane or hydrogen are measured in the exhaled breath. An additional advantage is that the location of the capsule is known, and therefore the source of gas production from increased bacterial load can be determined. Preliminary studies using the gas capsule have shown good correlation of patterns of breath H2 with those of regional H2 patterns generated by the gas-sensing capsule. In fact, the capsule demonstrated far greater sensitivity in measuring H2 production and a vastly superior signal-to-noise ratio in response to a fermentable load than breath testing. Hence, investigating the utility of the gas-sensing capsule as a means for 'direct' assessment of microbial density presents an opportunity to overcome the shortcomings associated with the current breath test.

Conditions

Small Intestinal Bacterial Overgrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Atmo Gas Capsule

Intervention Type: DEVICE

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.

Jejunal Aspiration and culture

Intervention Type: PROCEDURE

Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases

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.

Group Type: ACTIVE_COMPARATOR

Atmo Gas Capsule

Intervention Type: DEVICE

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.

Glucose Breath Test

Intervention Type: DIAGNOSTIC_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

Fructoolifosaccharides (FOS) Breath Test

Intervention Type: DIAGNOSTIC_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

Jejunal Aspiration and culture

Intervention Type: PROCEDURE

Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases

Rifaximin

Intervention Type: DRUG

Rifaximin (550g) 1 capsule twice a day for 14 days.

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.

Group Type: PLACEBO_COMPARATOR

Atmo Gas Capsule

Intervention Type: DEVICE

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.

Glucose Breath Test

Intervention Type: DIAGNOSTIC_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

Fructoolifosaccharides (FOS) Breath Test

Intervention Type: DIAGNOSTIC_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

Jejunal Aspiration and culture

Intervention Type: PROCEDURE

Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: PROCEDURE

Rifaximin

Rifaximin (550g) 1 capsule twice a day for 14 days.

Intervention Type: DRUG

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 Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atmo Biosciences Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Gerald Holtman, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status: RECRUITING

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Site Status: NOT_YET_RECRUITING

Countries

Australia; India

Central Contacts

Teressa Hansen, PhD

Role: CONTACT

Teressa.Hansen@health.qld.gov.au

07 3176 9190

Dr. Natasha Koloski

Role: CONTACT

n.koloski@uq.edu.au

+61 407 126 897

Facility Contacts

Teressa Hansen

Role: primary

Teressa.Hansen@health.qld.gov.au

07 3176 9190

Prof Uday Ghoshal, MD

Role: primary

udayghoshal@gmail.com

Shikha Sahu

Role: backup

shikha19sss@gmail.com

Other Identifiers

72853

Identifier Type: -

Identifier Source: org_study_id