search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Probiotics, Brain & Behavior


- candidate number24310
- NTR NumberNTR5845
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2016
- Secondary IDsNL55406.091.15 2015-2133
- Public TitleProbiotics, Brain & Behavior
- Scientific TitleImpact of a gut-microbiome intervention on neurocognitive measures of emotion and executive functioning
- ACRONYMProbiotics
- hypothesisThe aim of the present study is to investigate the effects of probiotic supplementation with Ecologic®Barrier on emotion processing and executive functioning in human subjects by using fMRI.
- Healt Condition(s) or Problem(s) studiedProbiotics, Emotions, Stress, Behaviour
- Inclusion criteriaInclusion criteria:
- Females taking hormonal contraceptives;
- Age: 18-40 years old;
- Dutch as a mother tongue or fluent in Dutch;
- Right-handed;
- BMI range between 18–25;
- Exclusion criteriaExclusion criteria:
- Previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history;
- Current or recent (<3 months) regular medication use;
- Previous or current substance/alcohol dependence or abuse within the last 3 months;
- Regular tobacco use (>5 cigarettes/day);
- Moderate alcohol use (>10 glasses a week);
- Antibiotic use 3 months prior to the study;
- Regular use of pre‐ and probiotics (and within 3 months prior to the study);
- Lactose Intolerance;
- Vegan Diet;
- Diet changed drastically over the last 3 months, or planning/willing to change diet drastically in the near future; - MRI incompatibility (unremovable metal objects in body [plates, screws, serrefines, dental plates (pontics), metal splinters, piercings or medical plasters], active implant [e.g. pacemaker, neuro stimulator, insulin pump and/or hearing aid], head operation, epilepsy, claustrophobia).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-mei-2017
- Target number of participants60
- Interventions28 days of 2g multi-species probiotic (Ecologic-®Barrier)/Placebo supplementation (1x daily)
- Primary outcomeNeurocognitive measures of emotion and executive functioning.
- Secondary outcomeNeuropsychological (questionnaires), physiological, and fecal measures.
- TimepointsFirst scanning session before starting probiotic supplementation (T0) and second scanning session within a week after the end of the intervention (T1).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr E. Aarts
- CONTACT for SCIENTIFIC QUERIESdr E. Aarts
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
TKI LSH, Winclove Probiotics B.V.
- Publications
- Brief summaryChanges in microbiota-gut- brain axis have been linked to alterations in emotional-cognitive behavior consistent with some anxiety and depressive symptoms. Recently, a growing body of animal studies proves evidences for effects of probiotics on gut microblome composition and functions. Accordingly, the present fMRI study aims to define the effects of probiotics supplementation on emotion, executive functioning and brain activity in a double-blind, placebo controlled design. Short term effects will be investigated after four weeks of supplementation with probiotics from the baseline in a Healthy human population.
- Main changes (audit trail)
- RECORD2-mei-2016 - 23-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl