Effect of Probiotics on Central Nervous System Functions in Humans

NCT02793193 | Completed Phase 2 DMC

• 1 other identifier: PITN-GA-2013-607652
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Stress

Outcome Measures

Primary Outcomes (1)

• Neural response to social stress measured by Magnetoencephalography

  8 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Active (rifaximin/B.longum 1714)

EXPERIMENTAL

Dietary Supplement: Probiotic; Drug: Antibiotic

Placebo

EXPERIMENTAL

Dietary Supplement: Placebo for antibiotic; Dietary Supplement: Placebo for probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic B.longum 1714 will be donated by Alimentary Health Ltd. (Cork, Ireland) and each sachet contains 10 billion CFU

Active (rifaximin/B.longum 1714)

Placebo for antibiotic DIETARY_SUPPLEMENT

The placebo supplementation is identical-looking to the antibiotic Xifaxan ®

Placebo

Antibiotic DRUG

Antibiotic Xifaxan ® will be 200mg per tablet

Active (rifaximin/B.longum 1714)

Placebo for probiotic DIETARY_SUPPLEMENT

The placebo identical-looking to the probiotic B.longum 1714

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female volunteers aged 18 to 50 years.
• 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,
• Participant is willing to comply with the study restrictions.
• Participant has been a non-smoker for at least 3 months.
• Participants with body mass index 18-30.

You may not qualify if:

• Participants are current smokers,
• Participants have chronic allergies,
• 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)),
• Participants received an immune-suppressing intervention or have an immunosuppressive illness within the last year,
• 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).
• Participants received antibiotic therapy within the last 2 months of their study start date.
• 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.
• Patients who do not meet the diagnosis criteria of IBS based on Rome I, II, or III (only for recruiting patients).

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen MEG Center

Tübingen, 72076, Germany

Location

Related Publications (1)

• 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.

  PMID: 29713909 DERIVED

MeSH Terms

Interventions

Probiotics; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Paul Enck, Prof. Dr.

  Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 8, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 2, 2020

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)