| CTRI Number |
CTRI/2024/07/070510 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to find out efficacy and safety of Bifidobacterium longum W11 plus Fructooligosaccharide combination in patients with irritable bowel syndrome |
|
Scientific Title of Study
|
Observational study to assess efficacy and safety of Bifidobacterium longum
W11 plus Fructooligosaccharide combination in patients with irritable bowel syndrome (IBS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMD/P/24/002 Version 1.0, Dated 28.05.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Garg |
| Designation |
Investigator |
| Affiliation |
Liver Gastro Clinic |
| Address |
Liver Gastro Clinic
AD- 5 Shalimar Bagh Delhi
North West
DELHI
110088
India |
| Phone |
9811226484 |
| Fax |
|
| Email |
rameshmddm@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Garg |
| Designation |
Investigator |
| Affiliation |
Liver Gastro Clinic |
| Address |
Liver Gastro Clinic
AD- 5 Shalimar Bagh Delhi
DELHI
110088
India |
| Phone |
9811226484 |
| Fax |
|
| Email |
rameshmddm@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jawahar Nidamboor |
| Designation |
Assistant Vice President |
| Affiliation |
Alpha MD Pvt Ltd |
| Address |
AlphaMD Pvt Ltd
21 Unique Ind Estate VS Marg 400025 Prabhadevi Mumbai Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9167254879 |
| Fax |
|
| Email |
jawahar.nidamboor@alphamd.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Ltd Floor 16 Godrej BKC Plot No C68 BKC Near MCA Club Bandra (E)
Mumbai India 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott India Ltd |
| Address |
Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E) Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Garg |
Liver Gastro Clinic |
Liver Gastro Clinic, AD 5-AD Block Bhagwan Mahavir Marg Shalimar Bagh Delhi 110088
North West
DELHI |
9811226484
rameshmddm@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Park Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bifidobacterium
longum W11 + Fructo-oligosaccharide (2.5g) |
FloraChampTM (Bifidobacterium longum W11 (5 bn) Fructo-oligosaccharide 2.5g), one sachet per day for 1 month to be given orally |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, aged between 18 and 60 years
OPD Patients with confirmed diagnosis of IBS with any of the three subtypes (viz IBS D/IBS C/IBS M)
Patients with no improvement in symptoms despite treatment with antispasmodics |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they have severe respiratory insufficiency organic brain damage sleep apnea syndrome severe acute or chronic
hepatic insufficiency (risk of occurrence of encephalopathy) myasthenia gravis chronic psychosis major depressive episodes
phobic or obsessional states or dementia
Patients with other pre-existing GI disorders GI surgery abnormal upper and lower GI endoscopy finding family history of colon cancer or inflammatory bowel disease symptoms that discriminate lower GI organic diseases from IBS such as blood in stool nighttime symptoms
that cause sleep disturbance unintentional weight loss or change in typical IBS symptoms such as new and/or different pain and alcohol or drug-dependency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean IBS-SSS total score from baseline at Day 30 |
Day 0, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in mean IBS-SSS total score from baseline at Day 15.
Change in mean score for each of the parameters in IBS-SSS (abdominal pain, number of days of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and
interference with Quality of Life) from baseline at Day 15 and Day 30
Proportion of patients showing normalization of stool form and frequency
Number and percentage of patients who discontinue study treatment due to AE
Global tolerability assessment by patients and investigators at Day 30 |
Day 0, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Irritable bowel syndrome (IBS) is a common condition, which leads to significant morbidity, work absenteeism, loss of productivity, and economic burden to the society and impacts the quality of life of patients. According to a systemic review, the bowel of patients with IBS is populated with potentially harmful microbiota (Enterobacteriaceae [Escherichia, Shigella, Campylobacter, and Salmonella], Lactobacillaceae and Bacteroides). It has been observed that Bifidobacterium and Faecalibacterium tend to decrease in patients with IBS. Probiotics are proven to have a beneficial impact on global IBS symptoms, abdominal pain, and flatulence. Among bacteria with a potential therapeutic effect, Bifidobacteria have certainly played a key role for several decades. Studies on regular consumption of fructo-oligosaccharides with minor bowel disorders have shown that regular consumption may improve Quality of life and digestive comfort in patients with IBS. Currently, there are no Indian clinical studies done using this combination. This study will provide the efficacy and safety data of the B. longum W11 plus Fructooligosaccharide combination in Indian IBS patients
The primary objectives of this study is the improvement in global IBS symptoms compared to baseline. The Secondary Objective of this study is to decrease the pain in abdomen compared to baseline, Proportion of patients showing improvement in abdominal distension, Proportion of patients showing normalization of stool form and frequency |