The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-05-31

Brief Summary

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This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.

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Detailed Description

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Conditions

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Major Depressive Disorder Depression Depressive Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participant

All participants will be experimental and receive Probio'Stick.

Group Type EXPERIMENTAL

Probio'Stick

Intervention Type DIETARY_SUPPLEMENT

A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Interventions

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Probio'Stick

A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI)
2. Current depressive episode with a MADRS score of ≥ 20
3. Males and females between ages 18 and 65
4. Able to understand and comply with the requirements of the study
5. Provision of written informed consent

Exclusion Criteria

1. Use of any antidepressant drug
2. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
3. Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
4. Milk, yeast, or soy allergy
5. History of alcohol or substance abuse in the past 6 months
6. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
7. Use of any type of laxative
8. Consumption of products fortified in probiotics
9. Severely suicidal
10. Experiencing psychosis or bipolar episode
11. History of epilepsy or uncontrolled seizures

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No