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

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 14, 2021

Primary Completion Date

June 1, 2024

Study Completion Date

August 1, 2024

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

Trial Locations (2)

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

226014,

NOT_YET_RECRUITING

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

Sponsors
All Listed Sponsors
lead

Atmo Biosciences Pty Ltd

INDUSTRY