NCT02793193|CompletedPhase 2/3DMC
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Sponsor study identifier
interventional
54
1 country
1
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Actual (reported)Study Completion
January 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2016
Actual (reported)June 8, 2016
Actual (reported)July 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 2018
Actual (reported)January 2018
Actual (reported)Neural response to social stress measured by Magnetoencephalography
8 weeks
Bacterial population levels in faecal samples
8 weeks
Cortisol levels in blood samples
8 weeks
Tryptophan levels in blood samples
8 weeks
Score of the Hospital Anxiety and Depression Scale (HADS)
8 weeks
Scores of the Positive and Negative Affect Scales (PANAS)
8 weeks
Probiotic B.longum 1714 will be donated by Alimentary Health Ltd. (Cork, Ireland) and each sachet contains 10 billion CFU
The placebo supplementation is identical-looking to the antibiotic Xifaxan ®
University Hospital Tuebingen MEG Center
Tübingen, 72076, Germany
Wang H, Braun C, Enck P. Effects of Rifaximin on Central Responses to Social Stress-a Pilot Experiment. Neurotherapeutics. 2018 Jul;15(3):807-818. doi: 10.1007/s13311-018-0627-2.
Paul Enck, Prof. Dr.
Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tuebingen
54 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2016
First Posted
June 8, 2016
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery
Antibiotic Xifaxan ® will be 200mg per tablet
The placebo identical-looking to the probiotic B.longum 1714
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2018
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
November 2, 2020
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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