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The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression

NCT02155972 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-11-08

No results posted yet for this study

Summary

This is an 8-week randomized, double-blind placebo-controlled proof of concept study assessing the combination of a mood stabilizer + Align in the treatment of participants with a bipolar depressive episode. The study has two treatment arms: mood stabilizer plus placebo and mood stabilizer plus Align.

The dose of mood stabilizer will be in accordance with clinical practice guidelines and the dose for Align will be 1 capsule per day as per appropriate product dosing.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium infantis

Probiotic supplement

OTHER

Placebo

Placebo capsules

Sponsors & Collaborators

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Valerie Taylor, PhD · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155972 on ClinicalTrials.gov