| CTRI Number |
CTRI/2022/04/041875 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating the safety and efficacy of the probiotics on IBS symptom severity in patients with diarrhoea-predominant Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
Evaluating the safety and efficacy of the probiotic Bifidobacterium
longum ES1 and the post biotic heat-treated Bifidobacterium longum
ES1 (HT-ES1) on IBS symptom severity in patients with diarrhoea predominant Irritable Bowel Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ADM/211001/BLE/IBS version 1.0 March 03, 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Principal Investigator |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vedic Lifesciences 118 - B Morya House, New Off link Road, Adarsh Nagar, Andheri west.
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Principal Investigator |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vedic Lifesciences 118 - B Morya House, New Off link Road, Adarsh Nagar, Andheri west.
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Zubair Ansari |
| Designation |
Project lead |
| Affiliation |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences 118 - B Morya House, New Off link Road, Adarsh Nagar, Andheri west.
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
7738945639 |
| Fax |
|
| Email |
zubair@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences
102 ACE business center near Navneet motors, Off old Agra road, Thane west |
|
|
Primary Sponsor
|
| Name |
Dr Malwina Naghibi |
| Address |
ADM Protexin Limited
Lopen Head SomersetTA135JH,UK |
| Type of Sponsor |
Other [Research industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aman Khanna |
Aman Hospital and research centre |
Aman Hospital and research centre, 15 Shaswat, Gotri Rd, opposite ESI
Hospital, Vadodara, Gujarat 390021
Vadodara
GUJARAT |
9904402122
amankhanna1974@gmail.com |
| Dr Jignesh Patel |
Apex Gastro Clinic and Hospital |
Apex Gastro Clinic and Hospital
B 310, Shivalik Yash, opp Shashtrinagar BRTS, 132 Feet Ring Rd, Naranpura,
Ahmedabad, Gujarat 380013
Ahmadabad
GUJARAT |
9727735536
drjigs2712@gmail.com |
| Dr Sanjeev Khanna |
Dr. Sanjeev Khanna clinic |
E - 002, Vishal Apartments, Behind Vishal Wedding Hall, Sir M V
Road, Andheri East, Mumbai, Maharashtra 400059
Mumbai (Suburban)
MAHARASHTRA |
9820055090
dr.sanjeevkhanna@yahoo.com |
| Dr Ram Parihar |
Gastroplus, Digestive disease centre |
Gastroplus, Digestive disease centre Vastrapur, Ahmedabad
Ahmadabad
GUJARAT |
9265407331
ramparihar1981@gmail.com |
| Dr Pankaj Singh Jadon |
Jaipur National University Institute for Medical Science & |
Jaipur National University Institute for Medical Science & Research
Centre Agra Road, Jagatpura, Jaipur, Rajasthan-302017.
Jaipur
RAJASTHAN |
9352781299
Drpankaj.medicine@jnujaipur.ac.in |
| Dr Avadhoot A Pandit |
Shantaee Nursing Home |
Shantaee Nursing Home, Charkop Bhavneet CHS LTD, Ground Floor,
'A' Wing, Plot No. 27 RSC 22/23, Sector 8, Kandivali West, Mumbai, Maharashtra
400067
Mumbai (Suburban)
MAHARASHTRA |
9820181625
avadhipt@gmail.com |
| Dr Ramesh R Dargad |
Stress test clinic |
A-4/1, Mukund Nagar CHS, Marol Pipeline Rd, Andheri East, Mumbai,
Maharashtra 400059
Mumbai (Suburban)
MAHARASHTRA |
9820152828
rohitdargad@outlook.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee, |
Approved |
| ACEAS Independent Ethics Committee, |
Approved |
| Harmony Ethical Research Commiittee Shree Hospital |
Approved |
| Harmony Ethical Research Commiittee Shree Hospital |
Approved |
| Harmony Ethical Research Commiittee Shree Hospital |
Approved |
| Institutional ethics committee, Aman Hospital and research centre, |
Approved |
| Jaipur National University Institute for Medical Science & Research Centre |
Approved |
| Jaipur National University Institute for Medical Science & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ES 1 |
Two capsules orally once daily after breakfast for 84 days |
| Intervention |
HT ES1 |
Two capsules orally once daily after breakfast for 84 days |
| Comparator Agent |
Placebo |
Two capsules orally once daily after breakfast for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Males and females aged ≥18 to ≤ 65 years.
2 Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria:
Related to defecation
Associated with a change in stool frequency (increase/decrease in frequency).
Associated with a change in the form (appearance) of stool.
ii) History of abnormal bowel movements predominantly diarrhoea (>25% of bowel movement categorised as stool form type 6 or 7 (diarrhoea) and <25% as stool form type 1 or 2 constipation) on BSFS).
3 Participants with an IBS-SSS score ≥ 175.
4 Participants who test negative for COVID-19 by Rapid Antigen Lateral Flow Test Device.
5 Participants who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
Female participants who are willing to use acceptable contraceptives during the study duration.
6 Participants who are literate enough to understand the purpose of the study and their rights.
7 Participants who are able to give written informed consent and are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1 Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥ 40.
2 Gluten and/or lactose intolerant individuals.
3 Abnormal Thyroid Stimulating Hormone (TSH) value which is (< 0.4 to > 4.2 mIU/L).
4 Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) > 199 mg/dL or fasting blood glucose (FBG) >125 mg/dL.
5 Participants with a body mass index (BMI) ≥ 30 kg/m2.
6 Presence of uncontrolled hypertension defined as systolic blood
pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
7 Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotic, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), FODMAP diet, and histamine H2- receptor antagonists/H2 blockers within six weeks prior to the screening day.
8 Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks before the screening day.
9 Participants with a history of bariatric surgery or surgical resection of
the stomach, small intestine, or large intestine.
10 Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.
11 Participants with a history of or complications from malignant tumours.
12 Participation in other clinical trials in the last 90 days prior to screening
13 Active smokers or using any form of smokeless tobacco.
14 Participants with substance abuse problems (within two years) defined as:
15 Use of recreational drugs (such as cocaine, methamphetamine,
marijuana, etc.)/Nicotine dependence.
16 High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol- containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol- containing beverages per week for men.
17 Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of investigational products on the participants
global assessment of gastrointestinal symptoms, as assessed by change in
IBS-Symptom Severity Scale (IBS-SSS) total score at the end of study
from baseline compared to placebo. |
day 0, 28, 56, and 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of the population achieving normal stool consistency
defined as l stool form type 3, 4, and 5 on Bristol Stool Form Scale |
day 0, 28, 56, and 84 |
| Quality of life as assessed by change in IBS-Quality of Life |
day 0, 28, 56 and 84 |
Abdominal pain severity as assessed by change in Abdominal Pain
Severity-Numeric Rating Scale (APS-NRS) score. |
day 0, 28, 56, and 84 |
Mental health as assessed by change in State-Trait Anxiety
Inventory-Adults (STAI-AD) score. |
day 0, 28, 56 and 84 |
| Vitals – blood pressure (BP) and pulse rate (PR). |
day 0, 28, 56, and 84 |
Gut microbiome as assessed by 16S rRNA sequencing of faecal
samples. |
day 0 and 84 |
Laboratory parameters (Alanine aminotransferase (ALT), Aspartate
aminotransferase (AST), Alkaline phosphatase (ALP), and
creatinine). |
day 0 and 84 |
The number of adverse events (AE)/serious adverse events (SAE)
occurred during the study compared to placebo. |
day 0, 28, 56, and 84 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2022 |
| Date of Study Completion (India) |
13/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/01/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present randomised controlled clinical study has been proposed to evaluate the safety and
efficacy of ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from IBS-D . |