| CTRI Number |
CTRI/2018/03/012276 [Registered on: 01/03/2018] Trial Registered Prospectively |
| Last Modified On: |
12/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotics and its effect on stress and sleep |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1199-2094 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor |
| Affiliation |
KIMS, Hubli, karnataka |
| Address |
Department of Anaesthesiology
Karnataka Institute of Medical Sciences(KIMS), Hubli, Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9449590556 |
| Fax |
0836-2278097 |
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor |
| Affiliation |
KIMS, Hubli, karnataka |
| Address |
Department of Anaesthesiology
Karnataka Institute of Medical Sciences(KIMS), Hubli, Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9449590556 |
| Fax |
0836-2278097 |
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor |
| Affiliation |
KIMS, Hubli, karnataka |
| Address |
Department of Anaesthesiology
Karnataka Institute of Medical Sciences(KIMS), Hubli, Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9449590556 |
| Fax |
0836-2278097 |
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Director, advanced research cell, Rajiv gandhi university of health sciences, jayanagar 4 th T blick, Bengaluru |
|
|
Primary Sponsor
|
| Name |
RGUHS bengaluru |
| Address |
4th T block Jayanagar bengaluru |
| Type of Sponsor |
Other [a medical university] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Director KIMS Hubli |
Karnataka Institute of Medical Sciences(KIMS) hubli |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhuri S Kurdi |
Karnataka Institute Of Medical Sciences |
Department of anaesthesia, room no 206, karnataka institute of medical sciences, Vidyanagar , Hubli, Karnataka, India
Dharwad
KARNATAKA |
9449590556
drmadhuri_kurdi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute Of Medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, patients admitted in hospital and posted for elective surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Probiotics is the study drug |
PROVIDAC CAPSULES WILL B ADMINISTERED AS PROBIOTICS oral capsules, once daily in the morning, for 4 consecutive days. |
| Comparator Agent |
VITAMIN B C0MPLEX CAPSULES |
these will act as placebo to probiotic capsules. These are administered as oral capsules, once daily for 4 consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 stress |
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 Outcome
|
| Outcome |
TimePoints |
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 stress |
one year three months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We have planned randomised double blind clinical trial which will explore the possibilty of a link between the gut microbiome , sleep and stress. We plan to alter the gut microbiome with a fast acting probiotic formulation containing lactobacillus and bifidobacterium species. in 160 patients aged between 16-65 years and posted for elective major surgeries. |