drugset / Trial / NCT02793193

Effect of Probiotics on Central Nervous System Functions in Humans

NCT02793193

Phase 2/3 Completed 54 enrolled University Hospital Tuebingen
RandomizedParallel-groupDouble-blindTreatment

Summary

The gut-brain axis is described as being important in both, gut functions and central nervous system (CNS) functions. The microbiota in the gut plays an important role in this axis through neural, immune and endocrine systems. Previous studies have found altered gut microbiota (GM) composition could change the CNS functions in animals and humans. Probiotics were shown having positive effect on improving stress response in animals and stress related psychiatry in humans. The current study will investigate if probiotics can improve response to social stress in healthy participants and patients with irritable bowel syndrome (IBS), which is a stress-related disease, and whether this probiotic action can be counteracted by the locally acting antibiotic, Rifaximin. The investigators will use the Cyberball paradigram to induce social stress and magnetoencephalography (MEG) to record neural responses related to the social stress. The administration of the probiotics will be a new strategy for both the mental health management and treatment of gastrointestinal (GI) disorders in the future.

Timeline

Start
2016-07
Primary completion
2018-01
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 600 mg

Indications

No indication recorded.