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Probiotics and stress

A RANDOMIZED, DOUBLE BLIND STUDY OF PROBIOTICS ON PHARMACY STUDENTS WITH EXAMINATION STRESS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018178
Enrollment
80
Registered
2019-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic capsules with glutamine : Each Capsule contains Proprietary probiotic blend of 10 billion cfu containing : Bacillus coagulans Unique IS2 Lactobacillus rhamnosus UBLR-58 B

Sponsors

Unique Biotech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Young adults with no reported cardiac, renal or hepatic conditions. 2. Adults having no allergies or intolerance to lactose or gluten. 3. Adults with no prescribed medication or drug use. 4. Adults who are reported to consume no more than 3-5 alcohol units per week. 5. Female students were not taking hormonal contraceptives. 6. Subjects who are not allergic to milk or milk products.

Exclusion criteria

Exclusion criteria: 1. Those who are already with adjuvant therapy like multivitamins. 2. Subjects who are not willing to participate or enrol. 3. Participation in any clinical study within the last 6 months. 4. Subjects who had probiotics 3 weeks before the inclusion. 5 Subjects with daily alcohol consumption > 30 gm. 6. Subjects with unstable physical illness and are bedridden. 7. Subjects meeting criteria for psychiatric disorders other than stress. 8. Subjects with co-morbidities or infection. 9. Subjects with current or recent antibiotic use. 10. Subjects with evidence of immunodeficiency, bleeding disorder or coagulopathy.

Design outcomes

Primary

MeasureTime frame
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]Timepoint: Visit 1- Treatment day ( Day 1) Visit 2- ( Day 29±2 )

Secondary

MeasureTime frame
1. To measure the serum cortisol level in stress before and after the treatmentTimepoint: Visit 1- Treatment day(Day 1) Visit 2- ( Day 29±2)

Countries

India

Contacts

Public ContactDr Rajesh Venkataraman

SAC College of pharmacy

rajeshvenky_research@hotmail.com9980038331

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026