Randomised clinical trial investigating the Efficacy of Probiotic Administration in ImpRoving depressive symptomatology - the REPAIR depression study.

Not Applicable

Completed

• Conditions: Depression; Mental Health - Depression; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613000438752
• Lead Sponsor: A/prof. Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Participants are older than 16 years of age.

Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol.

Participants meet at least one score above the cut-off of 11 on the QIDS or 14 on the DASS-42 depression subscale (moderate to very severe depression).

Participants are free of antidepressant and other psychiatric medications for at least four weeks prior to the trial.

Participants who have not recently, within the last 4 days, suffered illness or have signs of inflammation.

Exclusion Criteria

Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy).

Any serious medical condition for which major medical interventions are anticipated during the duration of the trial.

Any patient known to be allergic to the ingredients of the intervention.

Pregnancy or breastfeeding.

Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial.

Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.

Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.

Participants will be asked to minimize their intake of colas, tea, coffee, alcohol, cigarettes and illicit drugs. These substances will be monitored as part of the trial.

Participants will be excluded if they take the antidepressant herbal supplement, St John’s Wort.

Renal, hepatic, cardiovascular and respiratory diseases

Participants will be asked to cease their use of any type of nutritional or herbal supplement known to enhance the immune system (e.g. vitamin C, vitamin E, Echinacea) for the duration of the study as these may affect the efficacy of the probiotics.

Any person whose immune system is known to be weakened (e.g. by HIV/AIDS, a genetic defect, long-term use of corticosteroids or taking immunosuppressive medications).

Study & Design

• Study Type: Interventional
• Study Design: Not specified