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

NCT04910815 | Unknown

• 1 other identifier: 72853
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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

Conditions

Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (3)

• Structured Assessment of Gastro-Intestinal Symptoms

  22 item assessing gastrointestinal symptoms. Response items are on a 5-point scale from (1 )no problem to (5) very severe problem. This is given to patients attending the Department of Gastroenterology \& Hepatology at Princess Alexandra Hospital as part of their routine clinical care.

  30 minutes prior to endoscopy

• Hydrogen fermentation in the small intestine as measured by the Atmo capsule

  Approximately 30 minutes before the endoscopic procedure, participants will be asked to swallow the capsule (Atmo capsule), which is the size of a large vitamin pill. If the capsule still is in the stomach at the time of the procedure it will be endoscopically pushed into the small intestine. 5g of Fructooligosaccharide (FOS) in 25mL of water will be flushed via the working channel of the endoscope into the small intestine to ensure that carbohydrates are available for fermentation. Subsequently the capsule is propelled by the normal peristaltic waves through the whole gut and is excreted after several days with the faeces. During transit the capsule transmits data about the concentration of specific gases (e.g. hydrogen) in the gut to a small receiver outside of the body.

  30 minutes prior to endoscopy

• Small Intestine microbial load as assessed by Jejunal Aspiration and Culture

  The density of the bacterial colonisation of mucosal biopsies obtained during endoscpoy will be used to determine the role of the bacterial density

  During endoscpoic procedure

Secondary Outcomes (2)

• FOS Breath samples on the day of the endoscopy

  Up to 2 hours after the endescopic procedure

• Glucose Breath Test

  Not earlier than 12 hours after the endoscopic procedure

Study Arms (3)

Primary recruitment

EXPERIMENTAL

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.

Device: Atmo Gas Capsule; Procedure: Jejunal Aspiration and culture

Active SIBO Arm - Rifaximin

ACTIVE COMPARATOR

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.

Device: Atmo Gas Capsule; Diagnostic Test: Glucose Breath Test; Diagnostic Test: Fructoolifosaccharides (FOS) Breath Test; Procedure: Jejunal Aspiration and culture; Drug: Rifaximin

Active SIBO Arm - Placebo

PLACEBO COMPARATOR

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.

Device: Atmo Gas Capsule; Diagnostic Test: Glucose Breath Test; Diagnostic Test: Fructoolifosaccharides (FOS) Breath Test; Procedure: Jejunal Aspiration and culture; Drug: Placebo

Interventions

Atmo Gas Capsule 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.

Active SIBO Arm - Placebo; Active SIBO Arm - Rifaximin; Primary recruitment

Glucose Breath Test 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

Active SIBO Arm - Placebo; Active SIBO Arm - Rifaximin

Fructoolifosaccharides (FOS) Breath Test 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

Active SIBO Arm - Placebo; Active SIBO Arm - Rifaximin

Jejunal Aspiration and culture 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 - Placebo; Active SIBO Arm - Rifaximin; Primary recruitment

Rifaximin DRUG

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

Active SIBO Arm - Rifaximin

Placebo 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

Active SIBO Arm - Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atmo Biosciences Pty Ltd: lead

Study Sites (2)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014,, India

NOT YET RECRUITING

MeSH Terms

Interventions

Genes, fos; Breath Tests; Culture Techniques; Rifaximin

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Diagnostic Techniques and Procedures; Diagnosis; In Vitro Techniques; Investigative Techniques; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Professor Gerald Holtman, MD, PhD, MBA

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teressa Hansen, PhD

CONTACT

07 3176 9190; Teressa.Hansen@health.qld.gov.au

Dr. Natasha Koloski

CONTACT

+61 407 126 897; n.koloski@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 2, 2021
• Study Start: July 14, 2021
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); AU (1)