Effects of Probiotics on Mood

NCT03539263 | Completed

• 1 other identifier: 766CESC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in the psychological profile

  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.

  four evaluation sessions at intervals of three weeks of probiotic intervention

Secondary Outcomes (8)

• Evaluation of mood - State Trait Anxiety Inventory (STAI) standardized questionnarie.

  four evaluation sessions at intervals of three weeks of probiotic intervention

• Evaluation of mood - Beck Depression Inventory (BDI-2) standardized questionnarie.

  four evaluation sessions at intervals of three weeks of probiotic intervention

• Evaluation of mood - Profile od Mood State (POMS) standardized questionnarie.

  four evaluation sessions at intervals of three weeks of probiotic intervention

• Evaluation of the quality of sleep.

  four evaluation sessions at intervals of three weeks of probiotic intervention

• Evaluation of personality - Temperament and Character Inventory (TCI) standardized questionnarie.

  four evaluation sessions at intervals of three weeks of probiotic intervention

Study Arms (2)

Group 1

EXPERIMENTAL

the subjects are treated with probiotics: Bifihappy

Dietary Supplement: Bifihappy

Group 2

PLACEBO COMPARATOR

the subjects are treated with a placebo

Other: Placebo

Interventions

Bifihappy DIETARY_SUPPLEMENT

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

Group 1

Placebo OTHER

During the six weeks of treatment, the experimental group will take daily doses of 2,5 g of maltodextrin

Group 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Probiotical S.p.A.: lead
• Universita di Verona: collaborator

Study Sites (1)

University of Verona

Verona, 37131, Italy

Location

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 29, 2018
• Study Start: December 20, 2016
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from April 2018
• Access Criteria: Plos One

Locations

IT (1)