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Effects of Probiotics on Mood

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ClinicalTrials.gov Identifier: NCT03539263
Recruitment Status : Completed
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Probiotical S.p.A.

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE May 28, 2018
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE December 20, 2016
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Change in the psychological profile [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
The primary outcome is the difference in the scores at the Leiden Index of Depression Sensitivity-Revised test (LEIDS-R) standardized questionnaire between the experimental and control groups. The Leiden Index of Depression Sensitivity-Revised test, LEIDS-R, is a self-report questionnaire that tests cognitive reactivity to sad mood, which is an index of cognitive vulnerability to depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Evaluation of mood - State Trait Anxiety Inventory (STAI) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The State Trait Anxiety Inventory, STAI, is a self-report questionnaire that measures the presence and severity of current symptoms of anxiety and the propensity to be anxious.
  • Evaluation of mood - Beck Depression Inventory (BDI-2) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Beck Depression Inventory, BDI-2, is a self-report questionnaire that measures the occurrence and severity of current depressive symptoms.
  • Evaluation of mood - Profile od Mood State (POMS) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Profile of Mood State, POMS, is a self-report questionnaire that assesses mood.
  • Evaluation of the quality of sleep. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups in the standardized questionnaire Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index, PSQI, is a self-report questionnaire that assesses sleep quality for the majority of days and nights in the past months.
  • Evaluation of personality - Temperament and Character Inventory (TCI) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Temperament and Character Inventory, TCI, is a self-report, true-false questionnaire that measures two components of personality: temperament and character.
  • Evaluation of personality - Cope Orientation to Problem Experienced-New Italian Version (COPE-NIV) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Cope Orientation to Problem Experienced - New Italian Version, COPE-NIV, is a self-report questionnaire that measures coping strategies: the cognitive and behavioral strategies people use to manage stressful situations.
  • Evaluation of personality - Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Behavioral Inhibition and Behavioral Activation Scale, BIS/BAS, is a self-report questionnaire that measures an individual's sensitivity to behavioral inhibition and behavioral activation systems.
  • Evaluation of personality - Life Orientation Test-revisited (LOT-R) standardized questionnarie. [ Time Frame: four evaluation sessions at intervals of three weeks of probiotic intervention ]
    difference in the scores between the experimental and control groups. The Life Orientation Test-revisited, LOT-R, is a self-report measure of dispositional optimism and pessimism.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Probiotics on Mood
Official Title  ICMJE Randomized Controlled Experimental Trial Designed to Test the Effects of Probiotics on Mood
Brief Summary Recent demonstration that probiotics administration has positive effects on depressive feelings in healthy populations suggests its possible role as an adjuvant therapy for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. The present study extends current knowledge on the beneficial effects of probiotics on psychological well-being, as measured by changes in mood (e.g., depression, anxiety, cognitive reactivity to sad mood), personality dimensions, and quality of sleep, which have been considered as related to mood. For this double-blind, placebo-controlled study healthy volunteers pseudo-randomly assigned to an experimental or control group assumed a daily dose of probiotic or placebo, respectively, for 6 weeks. Mood, personality dimensions, and sleep quality were assessed four times (before the beginning of the study, at 3 and 6 weeks, and at 3 weeks of washout).
Detailed Description

A. THEORETICAL BACKGROUND The intestine and the brain are intimately connected with each other through the gut-brain axis, which involves bidirectional communication between the nervous, endocrine and immune systems. In the last years, it has become increasingly evident that this communication implies also interactions with the intestinal bacterial flora, which releases immune activation and other signalling molecules that may play a major role in the regulation of the brain and human behaviour. For instance, the microbiota produces neuroactive substances and their precursors (e.g. tryptophan) that may reach the brain through the endocrine and autonomous nervous system. Recently, the interest has been focused also on the cognitive field. Indeed, there is experimental evidence that bacterial products may positively influence cognitive functions, such as spatial memory and problem-solving abilities. Moreover, probiotics seem to exercise influence on mood, anxiety and depression, opening new therapeutic prospects. A recent trial showed that four weeks of taking probiotics (Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 e W58) led to an improvement in mood, fostering reduction in negative thoughts.

B. THE PURPOSE OF THE RESEARCH PROJECT The primary goal of the trial is to investigate the effect of probiotics on depression. Moreover, it will assess also effects on anxiety and other personality traits in healthy young students. The trial intends also to investigate whether probiotics may influence the quality of sleep and bowel habits. The trial will be placebo-controlled, randomized, pre- and post-intervention, double-blind designed (investigator and participants). In the light of the several end-points examined, the statistical analysis will be of explorative type.

The collection of faecal samples will allow, in case of finding any effects of the administered product on mood, to go back to any microbial components that have changed in individuals following the treatment. Monitoring (see below) the normal feed and physical habits of the individuals will allow to check the possible effect of these confounding factors on the parameters measured in the trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The trial design is parallel, with two groups (experimental group and control group) and four evaluation sessions at intervals of three weeks (T0wk = baseline, T3wk = intermediate, T6wk=final and T9wk = follow-up).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depression, Anxiety
Intervention  ICMJE
  • Dietary Supplement: Bifihappy

    During the six weeks of treatment, the experimental group will take daily doses of 2,5 g with a concentration of 4x109 CFU/sachet of a mixture of lyophilised probiotic strains of the following species:

    • Lactobacillus fermentum
    • Lactobacillus rhamnosus
    • Lactobacillus plantarum
    • Bifidobacterium longum
  • Other: Placebo
    During the six weeks of treatment, the experimental group will take daily doses of 2,5 g of maltodextrin
Study Arms  ICMJE
  • Experimental: Group 1
    the subjects are treated with probiotics: Bifihappy
    Intervention: Dietary Supplement: Bifihappy
  • Placebo Comparator: Group 2
    the subjects are treated with a placebo
    Intervention: Other: Placebo
Publications *

*   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: May 25, 2018)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and Famale subjects.
  • Aged between 18 and 35.
  • Already owing a smartphone with Android or iOS system.

Exclusion Criteria:

  • Drug taking, smoking, coeliac disease, lactose intolerance.
  • Disorders such as IBS (Irritable Bowel Syndrome), IBD (Irritable Bowel Disease), UC (Ulcerative Colitis) and other serious diseases, e.g. MS (Multiple Sclerosis) and diabetes (type 1/type 2).
  • Oral intake of antibiotics and other medicines on a continuative basis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539263
Other Study ID Numbers  ICMJE 766CESC
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: Yes
Plan Description: Study Protocol
Supporting Materials: Study Protocol
Time Frame: from April 2018
Access Criteria: Plos One
Responsible Party Probiotical S.p.A.
Study Sponsor  ICMJE Probiotical S.p.A.
Collaborators  ICMJE Universita di Verona
Investigators  ICMJE Not Provided
PRS Account Probiotical S.p.A.
Verification Date May 2018

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