Impact of a probiotic supplement on post-quake psychological distress and related biomarkers

Not Applicable

Withdrawn

• Conditions: Stress; Depression; Physical health; Mental Health - Other mental health disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12612000647831
• Lead Sponsor: niversity of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. Participants are older than 16 years of age.
2. 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.
3. Participants meet at least one score above the cut-offs of the Depression Anxiety and Stress scale(DASS; Lovibond & Lovibond, 1995).
4. Participants must have been in Christchurch at the time of the one of the major earthquake (September 4th 2010; February 22nd 2011; June 13th 2011; Dec 23rd 2011).
5. Participants are free of psychotropic medication for the trial.
6. Participants who have not recently, within the last 4 days, suffered illness or have signs of inflammation.

Exclusion Criteria

1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy).
2. Renal, hepatic, cardiovascular and respiratory diseases.
3. Any serious medical condition for which major medical interventions are anticipated during the duration of the trial.
4. Any patient known to have food allergy or to be allergic to the ingredients of the intervention.
5. Pregnancy or breastfeeding
6. Evidence of substance dependence within the previous month.
7. 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.
8. 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 If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.
9. Any type of nutritional or herbal supplement (ginger, guarana, ginseng, dehydroepiandrosterone, melatonin, antioxidants, selenium, replacement hormones) known to have a centrally-acting effect, will result in a patient’s exclusion.
10. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
11. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGI - clinical global impression for mood, stress, anxiety and energy - from 1 to 7 how much better or worse from very much improved to very much worse. Assessed by participant.[RCT: Baseline and fortnightly for all the 8 week period.<br><br>Open-label extension: fortnightly for the 8 week period.];The Depression Anxiety and Stress Scale (DASS) is a self-report questionnaire aimed at assessing an individual's current severity of symptoms relating to depression, anxiety and stress.[RCT: Baseline and fortnightly for the 8 week period.<br><br>Open-label extension: fortnightly for the 8 week period.];Assessment of biomarkers:<br><br>- salivary cortisol<br>- high-sensitive C-reactive protein (blood)<br>- homocysteine (blood)[Baseline and 8 weeks (end of RCT phase).]