Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
Small Intestinal Bacterial Overgrowth
About this trial
This is an interventional diagnostic trial for Small Intestinal Bacterial Overgrowth
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
Sites / Locations
- Princess Alexandra HospitalRecruiting
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Primary recruitment
Active SIBO Arm - Rifaximin
Active SIBO Arm - Placebo
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.
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.
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.