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Trial record 1 of 1 for:    NCT03615651
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Probiotic Effects on the Microbe-brain-gut Interaction and Brain Activity During Stress Tasks in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03615651
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE January 22, 2018
Actual Primary Completion Date June 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Change in brain response to validated emotional challenge task (EAT) during functional brain imaging [ Time Frame: Comparing week 4 and 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Change in brain response to a cognitive challenge task (MIST) during functional brain imaging [ Time Frame: Comparing week 4 and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 30, 2018)
  • Change in physical activity assessed by an actigraphy watch (actiwatch) [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Actigraph data regarding physical activity
  • Change in sleep quality assessed by an actigraphy watch (actiwatch) [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Actigraph data regarding sleep quality
  • Change in daily stress levels assessed by an actigraphy watch (actiwatch) [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Actigraph data regarding daily stress levels
  • Autonomous Nervous System (ANS) Activity, Biopac [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    ANS activity is measures during stressful tasks.
  • Stroop test [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    The Stroop test is performed for stress induction
  • HADS (Hospital Anxiety and Depression Scale) [ Time Frame: Measured weekly, week 1-12 ]
    Hospital Anxiety and Depression Scale, min score 0, max score 3, total score max 42, subscale anxiety max 21, subscale depression max 21
  • STAI (State and Trait Anxiety Inventory for Adults) [ Time Frame: Measured weekly, week 1-12 ]
    State and Trait Anxiety Inventory for Adults
  • PSS (Perceived Stress Scale) [ Time Frame: Measured weekly, week 1-12 ]
    Perceived Stress Scale, min score 0, max score 40
  • Euro-QoL [ Time Frame: Measured weekly, week 1-12 ]
    Euro Qol- Health-related Quality of Life 5Q-5D-5L, min score 0, max score 20, subscale 0-100
  • Karolinska Sleep Diary (KSD) [ Time Frame: Measured daily, week 1-4 and 8-12 ]
    KSD measures sleep quality in the morning
  • Karolinska Diary of Workload (KDW) [ Time Frame: Measured daily, week 1-4 and 8-12 ]
    KDW measures workload daily in the evening
  • Cortisol levels during fMRI tasks (Saliva) [ Time Frame: Comparing week 4 and 12 ]
    Saliva samples are collected during fMRI to assess cortisol levels
  • Cortisol awakening rhythm (saliva) [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Saliva samples are collected at home (3 days á 5 samples) to assess cortisol levels
  • Faecal samples [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Faecal samples will be analyzed for quantitative and qualitative microbial composition by 16S rRNA-based next generation sequencing (NGS)
  • Change in inflammatory markers [ Time Frame: Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods) ]
    Blood samples will be collected after each intervention period to assess inflammatory markers using Enzyme-Linked Immunosorbent Assays (ELISA)s
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Probiotic Effects on the Microbe-brain-gut Interaction and Brain Activity During Stress Tasks in Healthy Subjects
Official Title  ICMJE Probiotic Effects on the Microbe-brain-gut Interaction and Brain Activity During Stress Tasks in Healthy Subjects
Brief Summary The aim of this study is to determine if and how the "Probiotic Product" affects functional brain responses in healthy subjects during an emotional- and arithmetic stress task, respectively and in terms of microbe-brain-gut interactions.
Detailed Description

The aim of this study is to determine if and how the "Probiotic Product" affects functional brain responses in healthy subjects during an emotional- and arithmetic stress task, respectively and in terms of microbe-brain-gut interactions.

In this randomized double-blind placebo-controlled study, n=22 healthy subjects will receive the following interventions in a crossover fashion, separated by a 4-week wash-out period: 1) Probiotic Formula, 2) placebo. After baseline assessments, study participants will start with a 4-week intervention with the study product or the placebo, followed by a 4-week wash-out period and a subsequent 4-week intervention period (placebo or study product, respectively). fMRI (functional magnetic resonance imaging) scanning during two validated stress tasks will be performed after each of the intervention periods (week 4 and week 12). At the same time points and in addition on the days before the 1st and 2nd intervention (baseline 1 and 2), saliva, blood and faecal samples will be collected. Questionnaire data will be collected and psychological tests and instruments will be performed. For one week at baseline and during the intervention periods (last week), subjects will wear actigraphs to record their physical activity and help assess sleep quality. At baseline, subjects will undergo a carbon dioxide (CO2) challenge test as well as a food diary to record dietary habits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Probiotics
  • Gut Microbiota
  • Emotional Stress
  • Magnetic Resonance Imaging
Intervention  ICMJE
  • Dietary Supplement: Probiotic
    The Probiotic Formula is commercially available and contains a combination of 3 probiotic strains in addition to other nutrients. The total daily amount of probiotic strain in the product will be no less than 3 billion colony-forming units (CFU) per 3 g powder sachet.
  • Other: Placebo
    Placebo intervention.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    All study participants will receive the study product and the placebo in a randomized, double-blind crossover fashion. Probiotic and placebo products have similar appearance and taste.
    Intervention: Other: Placebo
  • Experimental: Probiotic
    All study participants will receive the study product and the placebo in a randomized, double-blind crossover fashion. Probiotic and placebo products have similar appearance and taste.
    Intervention: Dietary Supplement: Probiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2018)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 16, 2018
Actual Primary Completion Date June 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: Age: 18-65 years, males/females.
  2. Signed informed consent -

Exclusion Criteria:

  1. Concurrent or recent treatment with drugs affecting intestinal function or mood, e.g., antidepressants (< 12 weeks) or antibiotics (< 12 weeks).
  2. Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort, fibers, prebiotics and probiotics).
  3. Diagnosis of major psychiatric or somatic disease. 4) Abuse of alcohol or drugs. 5) Recent (< 4 weeks) intake of proton pump inhibitors, proton pump inhibitors, PPIs (e.g., omeprazole).

6) Asthma. 7) Cardiovascular diseases. 8) Epilepsy. 9) Renal failure. 10) Cerebral bleeding or history of cerebral bleeding. 11) Allergic to latex. 12) Pregnancy (assessed by urine test) or breastfeeding. 13) Claustrophobia. 14) Smoking or using tobacco including snuff. 15) Inability to maintain exercise routine and dietary pattern during the study.

16) Consumption of more than 6 cups of coffee/caffeine-containing beverages per day.

17) Professional athlete. 18) Dominant left-hand. 19) Medical implant (e.g., pacemaker). 20) Aneurysm clips in the head. 21) Shunts in the head. 22) Grenade-splinter or metal-splinter in the body (e.g., eyes). 23) Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlea implant).

24) Comprehensive tooth-implants or prothesis. 25) Operated in the head. 26) Operated in the heart. 27) Swallowed a video-capsule. 28) Non-corrected astigmatism. 29) Regular intake of systemic corticosteroids and anti-inflammatory medication (including NSAIDs) during the last three months.

30) Visual defect without possibility to use lenses during MRI scanning. 31) Known allergy to milk or soy. 32) Any other reason the investigator feels the subject is not suitable for participation in the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03615651
Other Study ID Numbers  ICMJE 2017/398
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert Brummer, Örebro University, Sweden
Study Sponsor  ICMJE Örebro University, Sweden
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Robert Brummer, Prof Örebro University, Sweden
PRS Account Örebro University, Sweden
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP