Effect of Probiotics on Central Nervous System Functions in Humans
NCT02793193 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2020-11-02
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.
Conditions
- Social Stress
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic
Probiotic B.longum 1714 will be donated by Alimentary Health Ltd. (Cork, Ireland) and each sachet contains 10 billion CFU
- DIETARY_SUPPLEMENT
-
Placebo for antibiotic
The placebo supplementation is identical-looking to the antibiotic Xifaxan ®
- DRUG
-
Antibiotic
Antibiotic Xifaxan ® will be 200mg per tablet
- DIETARY_SUPPLEMENT
-
Placebo for probiotic
The placebo identical-looking to the probiotic B.longum 1714
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Principal Investigators
-
Paul Enck, Prof. Dr. · Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tuebingen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2018-01-31
- Completion
- 2018-01-31
Countries
- Germany
Study Locations
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