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Non-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

Non-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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000663550
Enrollment
192
Registered
2024-05-24
Start date
2025-10-22
Completion date
2026-06-02
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Disorders of Brain Gut Interaction (DGBIs) are extremely common affecting up to onein three Australians. These conditions are chronic, resulting in reduced quality of life for patients and are responsible for substantial health care utilisation. This is largely due to the fact that routinely available treatments do not provide the required symptom relief and long-term improvement of quality of life. In recent times, small intestinal dysbiosis has been identified as a potential cause for DGBI. Small intestinal bacterial dysbiosis refers to an expansion of unfavorable or harmful bacteria in the small intestinal tract. While antibiotics such as rifaximin are proven to improve symptoms in patients with DGBI, there are concerns in relation to antibiotic resistance and antibiotics are not suitable for long term treatment. Previous data suggest that simethicone can be beneficial in DGBI patients and our recent in-vitro data reveal a suppression of growth of bacteria obtained from the small intestine. Thus, we aim to conduct a randomised placebo-controlled trial to test the readily available (over the counter) treatment Simethicone as a means to target the imbalance of bacteria lining the small intestine in patients with DGBI.

Interventions

Participants will be randomised to receive oral simethicone either 1ml or 2ml for 6 weeks Adherence will be monitored by IP accountability, drug tablet return.

Sponsors

Metro South Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026