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

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

Conditions

• Small Intestinal Bacterial Overgrowth

Interventions

DEVICE

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.

DIAGNOSTIC_TEST

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

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

PROCEDURE

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

DRUG

Rifaximin

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

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

Sponsors & Collaborators

• Atmo Biosciences Pty Ltd

  lead INDUSTRY

Principal Investigators

• Professor Gerald Holtman, MD, PhD, MBA · The University of Queensland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-14

Primary Completion

2024-06-01

Completion

2024-08-01

Countries

• Australia
• India

Study Locations