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Effect of Probiotics on Central Nervous System Functions in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02793193
Recruitment Status : Unknown
Verified May 2016 by University Hospital Tuebingen.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Social Stress Dietary Supplement: Probiotic Dietary Supplement: Placebo for antibiotic Drug: Antibiotic Dietary Supplement: Placebo for probiotic Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Probiotics on Central Nervous System Functions in Humans
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: Probiotic then antibiotic
Participants take probiotic B. longum 1714 for 4 weeks, and then antibiotic Xifaxan ® for another 4 weeks.
Dietary Supplement: Probiotic
Probiotic B.longum 1714 will be donated by Alimentary Health Ltd. (Cork, Ireland) and each sachet contains 10 billion CFU

Drug: Antibiotic
Antibiotic Xifaxan ® will be 200mg per tablet

Experimental: Probiotic then placebo
Participants take probiotic B. longum 1714 for 4 weeks, and then placebo for antibiotic Xifaxan ® for another 4 weeks.
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 ®

Experimental: Antibiotic then placebo
Participants take antibiotic Xifaxan ® for 4 weeks, and then placebo for probiotic B.longum 1714 another 4 weeks.
Dietary Supplement: Placebo for antibiotic
The placebo supplementation is identical-looking to the antibiotic Xifaxan ®

Drug: Antibiotic
Antibiotic Xifaxan ® will be 200mg per tablet

Experimental: Antibiotic then probiotic
Participants take antibiotic Xifaxan ® for 3 weeks, and then wash out by taking placebo for antibiotic Xifaxan ® for 1 week, and then take probiotic B.longum 1714 for another 4 weeks.
Drug: Antibiotic
Antibiotic Xifaxan ® will be 200mg per tablet

Dietary Supplement: Placebo for probiotic
The placebo identical-looking to the probiotic B.longum 1714

Placebo Comparator: Placebo then placebo
Participants take placebo for antibiotic Xifaxan ® for 4 weeks, and then placebo for another 4 weeks.
Dietary Supplement: Placebo for antibiotic
The placebo supplementation is identical-looking to the antibiotic Xifaxan ®

Dietary Supplement: Placebo for probiotic
The placebo identical-looking to the probiotic B.longum 1714




Primary Outcome Measures :
  1. Neural response to social stress measured by Magnetoencephalography [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Bacterial population levels in faecal samples [ Time Frame: 8 weeks ]
  2. Cortisol levels in blood samples [ Time Frame: 8 weeks ]
  3. Tryptophan levels in blood samples [ Time Frame: 8 weeks ]
  4. Score of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 8 weeks ]
    the RAND 36-Item Healthy Survey

  5. Scores of the Positive and Negative Affect Scales (PANAS) [ Time Frame: 8 weeks ]
  6. Scores of the RAND 36-Item Healthy Survey [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female volunteers aged 18 to 50 years.
  2. Signed informed consent. Written informed consent will need to be obtained from all participants, and the protocol will be submitted to the Ethics Board of the Medical School for approval,
  3. Participant is willing to comply with the study restrictions.
  4. Participant has been a non-smoker for at least 3 months.
  5. Participants with body mass index 18-30.

Exclusion Criteria:

  1. Participants are current smokers,
  2. Participants have chronic allergies,
  3. Participants are unwilling to discontinue the consumption of probiotic- and prebiotic-containing foods or potentially immune-enhancing dietary supplements (i.e. prebiotics, probiotics, Echinacea, fish oil and vitamin E (>400 % of the RDA or .60 mg/d)),
  4. Participants received an immune-suppressing intervention or have an immunosuppressive illness within the last year,
  5. Participants have a psychiatric disorder (eg. depression, anxiety, dysthymia, panic disorder, disorder of mania or bipolar disorder, phobia, post-traumatic stress disorder, substance abuse, eating disorder) (only for recruiting healthy volunteers).
  6. Participants received antibiotic therapy within the last 2 months of their study start date.
  7. Participants have non-removable metal parts in the body such as: pacemaker, artificial heart valves, metal prostheses, implanted magnetic metal parts (screws), spiral, metal fragments / shrapnel, fixed braces, acupuncture needle, insulin pump, tattoos, eye shadow. Also, people with agoraphobia will be excluded.
  8. Patients who do not meet the diagnosis criteria of IBS based on Rome I, II, or III (only for recruiting patients).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793193


Contacts
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Contact: Christoph Braun, Prof. Dr. +49(0)7071-2997705 christoph.braun@uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen MEG Center
Tuebingen, Germany, 72076
Contact: Christoph Braun, Prof. Dr.         
Principal Investigator: Paul Enck, Prof. Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Paul Enck, Prof. Dr. Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tuebingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02793193    
Other Study ID Numbers: PITN-GA-2013-607652
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Rifaximin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Gastrointestinal Agents