Probiotics and stress

Phase 4

Completed

• Conditions: Examination stress

• Registration Number: CTRI/2019/03/018178
• Lead Sponsor: Unique Biotech Limited

Brief Summary

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|This study is to evaluate the role of probiotics in the management of stress. Stress in biological terms refers to the reaction of the body to the distrubance of eqililbrium given particular stimuli. Stress also changes behavior. It has been hypothesized that exposure to stress and negative life event is related to poor health outcome. Beyond the certain point, stress can also trigger the onset of serious mental health problem. Higher levels of cortisol indicate greater psychological stress.

Studies on probiotics in the management of health professional with stress due to examination shall be a boon among educational research in India and one of a kind in mental health promotion.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-04
• Study Completion: 2019-06-16
• Last Update Posted: 2019-12-07

Recruitment & Eligibility

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

Inclusion Criteria

• Young adults with no reported cardiac, renal or hepatic conditions.
• Adults having no allergies or intolerance to lactose or gluten.
• Adults with no prescribed medication or drug use.
• Adults who are reported to consume no more than 3-5 alcohol units per week.
• Female students were not taking hormonal contraceptives.
• Subjects who are not allergic to milk or milk products.

Exclusion Criteria

• Those who are already with adjuvant therapy like multivitamins.
• Subjects who are not willing to participate or enrol.
• Participation in any clinical study within the last 6 months.
• Subjects who had probiotics 3 weeks before the inclusion.
• 5 Subjects with daily alcohol consumption > 30 gm.
• Subjects with unstable physical illness and are bedridden.
• Subjects meeting criteria for psychiatric disorders other than stress.
• Subjects with co-morbidities or infection.
• Subjects with current or recent antibiotic use.
• Subjects with evidence of immunodeficiency, bleeding disorder or coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the effect of probiotics in the treatment of stress using questionnaires- State - Trait Anxiety Inventory [STAI], Perceived Stress Scale [PSS], Depression Anxiety Stress Scale [DASS]	Visit 1- Treatment day ( Day 1) | Visit 2- ( Day 29±2 )

Secondary Outcome Measures

Name	Time	Method
1. To measure the serum cortisol level in stress before and after the treatment	Visit 1- Treatment day(Day 1)

Trial Locations

Locations (1)

Adichunchanagiri Hospital And Research Center; 🇮🇳 Mandya, KARNATAKA, India

Adichunchanagiri Hospital And Research Center

🇮🇳Mandya, KARNATAKA, India

Dr Vinay H R

Principal investigator

8904093422

drvinayhr@bgsaims.edu.in