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Probiotics and its effect on stress and sleep

USE OF NON-INVASIVE BIOMARKERS TO ASSESS THE ROLE OF PROBIOTICS IN SLEEP REGULATION AND STRESS ATTENUATION IN SURGICAL PATIENTS- A RANDOMISED DOUBLE BLIND CLINICAL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012276
Enrollment
160
Registered
2018-03-01
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

Health Condition 1: R69- Illness, unspecified Health Condition 2: null- patients admitted in hospital and posted for elective surgeries

Interventions

Intervention1: Probiotics is the study drug: PROVIDAC CAPSULES WILL B ADMINISTERED AS PROBIOTICS oral capsules, once daily in the morning, for 4 consecutive days. Control Intervention1: VITAMIN B C0MP

Sponsors

RGUHS bengaluru
Lead Sponsor
Director KIMS Hubli
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1) Female/ male patients posted for elective major surgeries under central neuraxial block or general anaesthesia 2)Age between 20-65 years. 3) Having ability to read, hear, write and speak Kannada to answer the questionnaire.

Exclusion criteria

Exclusion criteria: 1)Patients on chemotherapy / radiotherapy 2)Patients with diseases of the gut/ GI symptoms/psychiatric symptoms 3)Patients with oral lesions 4)On oral antacids/ antidiabetics/antibiotics 5) Patients with history of gastric bypass surgery Those with moderate /severe pain

Design outcomes

Primary

MeasureTime frame
1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress. 2. To find out if the gut microbiome affects surgery related sleep and stressTimepoint: 1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress on the 4 th day evening before the scheduled surgery between 8 to 9 pm.. 2. To find out if the gut microbiome affects surgery related sleep and stress on 4 th day evening before surgery between 8 and 9 pm.

Secondary

MeasureTime frame
SECONDARY OBJECTIVES: 1. To find out whether probiotics alter the impact of the gut microbiome on surgery related sleep and stress. 2. To find out if the gut microbiome affects surgery related sleep and stressTimepoint: one year three months

Countries

India

Contacts

Public ContactDr Madhuri S Kurdi

KIMS, Hubli, karnataka

drmadhuri_kurdi@yahoo.com9449590556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026