Effect of Probiotics on Central Nervous System Functions in Humans

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Rifaximin

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).