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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793193 on ClinicalTrials.gov