150
Participants
Start Date
July 14, 2021
Primary Completion Date
June 1, 2024
Study Completion Date
August 1, 2024
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.
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
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
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
Rifaximin
Rifaximin (550g) 1 capsule twice a day for 14 days.
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
RECRUITING
Princess Alexandra Hospital, Woolloongabba
NOT_YET_RECRUITING
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
Lead Sponsor
Atmo Biosciences Pty Ltd
INDUSTRY