on-antibiotic modulation of small intestinal dysbiosis with oral simethicone as a treatment for patients with disorders of gut-brain interaction: a randomised placebo-controlled trial

Phase 3

• Conditions: Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Disorders of gut brain interaction

• Registration Number: ACTRN12624000663550
• Lead Sponsor: Metro South Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-24
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1)H. pylori negative patients with a diagnosis of a DGBI (Rome IV criteria) with a negative diagnostic work-up for organic disease.

2)Only patients routinely undergoing gastrointestinal endoscopies for the diagnostic work-up of otherwise unexplained gastrointestinal symptoms will be recruited.

3)Over 18 years of age

Exclusion Criteria

1)unsuitable for therapy due to any medical conditions, drug allergies or inability to attend follow-up appointments
2)undergoing psychiatric treatment (e.g., full doses of antipsychotic, anxiolytic or antidepressant medication)
3)insufficient language or literacy skills
4)antibiotic use in the previous 3 months.
5)unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms[Gastrointestinal Symptom Score (GIS) questionnaire Pre treatment, 4 and 12 weeks post treatment.<br><br>4 weeks post treatment is the primary timepoint];Gastrointestinal symptom intensity[Structured Assessment of Gastro-Intestinal Symptoms Pre treatment, 4 and 12 weeks post treatment.<br><br>4 weeks post treatment is the primary timepoint];Density of bacterial colonisation[Density of bacterial colonisation of mucosal biopsies obtained from the 2nd part of the duodenum using the Brisbane Asceptic Biopsy device Pre treatment, 4 and 12 weeks post treatment.<br><br>4 weeks post treatment is the primary timepoint]