Status:
COMPLETED
Probiotics, Brain Structure and Psychological Variables
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Depressive Symptoms
Anxiety
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota, immunological and hormonal responses, brain function, brain structure, as well as resulting behavio...
Detailed Description
A double-blind RCT intervention study will be conducted to investigate the effect of a probiotic dietary supplement vs. a placebo, taken by healthy human participants (N = 60) for 28 consecutive days....
Eligibility Criteria
Inclusion
- healthy participants
- age 18-40
- informed consent for all parts of the study (including MRT)
- none of the exclusion criteria (see below) fulfilled
Exclusion
- age \< 18 or \> 40 years
- pregnancy or breastfeeding
- left-handedness
- degenerative or inflammatory diseases of the central nervous system
- severe cognitive/ neuropsychological impairment
- severe pain syndrome or other severe organic diseases
- epilepsy
- (past or present) psychiatric disorders
- neurological disorder
- severe diabetic polyneuropathy
- malignancies/ cancer
- cardiac insufficiency
- arterial hypertension
- heart attack/ stroke
- severe hepatic or renal insufficiency
- diseases of the hemopoietic system
- alcoholism/ drug addiction
- medical history of severe allergic or toxic reactions
- current participation in drug trial
- doubts about legal capacity/ capability of understanding
- referral to institutions based on court/ official order
- treatment with centrally acting medication (e.g. antipsychotics, antiepileptics, antidepressants, etc.)
- non-removable metal pieces (aneurysm clips, artificial limbs, etc.) or implanted electronic devices (pacemaker, osmotic or other implanted pumps, cochlear implants, etc.)
- claustrophobia
- acute (respiratory) infection, physical uneasiness
- tattoos in the head region, permanent make-up
- non-removable piercings
- chronic/ acute gastrointestinal diseases
- vegetarianism, veganism
- current intake of antibiotics or intake of antibiotics at any time point during the last 2 months
- lactose intolerance
- general focus on probiotic diet
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03478527
Start Date
January 8 2018
End Date
January 28 2021
Last Update
February 9 2021
Active Locations (1)
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1
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Hamburg, Germany, 20246