| CTRI Number |
CTRI/2014/05/004587 [Registered on: 09/05/2014] Trial Registered Prospectively |
| Last Modified On: |
19/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Synbiotic Formulation in Human Subjects |
|
Scientific Title of Study
|
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Synbiotic Formulation in Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KL_ITINGI04_Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hardik Satish Shah |
| Designation |
Principal Investigator |
| Affiliation |
Bhatia Hospital |
| Address |
Bhatia General Hospital Medical Research Society
Department of Gasteroenterology
Tardeo Road
Grant Road (W)
Mumbai
MAHARASHTRA
400007
India |
| Phone |
022-66660630 |
| Fax |
022-66660566 |
| Email |
doctorhardikshah@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hardik Satish Shah |
| Designation |
Principal Investigator |
| Affiliation |
Bhatia Hospital |
| Address |
Bhatia General Hospital Medical Research Society
Department of Gasteroenterology
Tardeo Road
Grant Road (W)
Mumbai
MAHARASHTRA
400007
India |
| Phone |
022-66660630 |
| Fax |
022-66660566 |
| Email |
doctorhardikshah@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Simran Sethi |
| Designation |
Director- Operations, Personal Healthcare |
| Affiliation |
Karmic Lifesciences LLP |
| Address |
Karmic Lifesciences LLP
Ground Floor, Unit no. 2,
Reliable Plaza, Thane Belapur Road,
Airoli, Navi Mumbai
Thane
MAHARASHTRA
400708
India |
| Phone |
079-66135618 |
| Fax |
|
| Email |
simran.sethi@karmiclifesciences.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Limited |
| Address |
ITC Life Science and Technology Center
Peenya Industrial Area, 1st Phase,
Bangalore - 560058 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Karmic Lifesciences |
802, Building No. 3,
Raheja Mind Space(SEZ), Plot No. 3,
TTC Industrial Area, Airoli,Navi Mumbai - 400708 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hardik Satish Shah |
Bhatia Hospital |
Ground floor, Department of Gasteroenterology, Bhatia General Hospital Medical Research Society
Tardeo Road, Grant Road (W), India-400007
Mumbai
MAHARASHTRA |
022-66660630
doctorhardikshah@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhatia Hospital Medical Research Society Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
To be taken just before food (preferably with lunch and dinner) twice a day for 21 Days. Investigational product presented in sachets can be reconstituted (in one glass {around 250ml} water) prior to administration.Each sachet contain 4 g of powder to be taken orally |
| Intervention |
Test Product |
To be taken just before food (preferably with lunch and dinner) twice a day for 21 Days. Investigational product presented in sachets can be reconstituted (in one glass {around 250ml} water) prior to administration. Each sachet contain 4 g of powder to be taken orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females aged from 18 to 65 years, both inclusive.
2. Subjects with active symptoms of abdominal pain or discomfort.
3. IBS diagnosed by Rome III criteria:
4. Functional Constipation diagnosed by Rome III criteria:
5. Females of child-bearing potential should be willing to use adequate methods of contraception.
6. Subjects willing to provide a written and recorded informed consent
7. Subjects with no regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit. |
|
| ExclusionCriteria |
| Details |
1. Major gastrointestinal complication (e.g. Crohns disease, ulcer, cancer).
2. The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced medical condition.
3. The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
4. The subject had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery).
5. IBS subtype other than IBS associated with Constipation.
6. Diarrhoea (more than 3 bowel movements per day).
7. Consumption of probiotics or prebiotics within 2 weeks of randomization.
8. Antibiotic use within 4 weeks of randomization.
9. Laxative or other constipation medication use within 2 weeks of randomization.
10. Subjects on the ongoing therapies with the drugs known to effect gut motility (e.g. laxatives, prokinetics, etc).
11. Consumption of IBS medications, anti-depressants, pain reliever medications within ten days prior to treatment or during treatment.
12. Subject with eating disorder.
13. Known allergies to any substance in the study product, including lactose intolerance and galactosemia.
14. Pregnant or lactating women.
15. History of alcohol, drug, or medication abuse.
16. Participation in another study with any investigational product (IP) within 3 months of randomization.
17. Subject with any condition that might interfere with the conduct of the study as per Investigators opinion. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction of Colonic Transit, Colonic Geometric Center at 24 hours between the groups by Scintigraphy as compared to baseline |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Colonic Filling |
6 hours |
| Change in Half Time (t½) of Gastric Emptying of Solids |
0,1,2 Hours |
| Relief from abdominal symptoms between the groups by Subject Global Assessment of Relief using a 5-point Likert scale |
baseline to Day 4, Day 9, Day 16, Day 24 and Day 38 |
| Change in Investigator‟s Assessment on abdominal symptoms using a 5-point Likert scale between the groups |
baseline to Day 9, Day 16, Day 24 and Day 38 |
| Change in Subject‟s Assessment on abdominal symptoms (using a 5-point Likert scale between the groups. |
baseline to Day 9, Day 16, Day 24 and Day 38 |
| Change in number of stool frequency between the groups |
baseline to Day 9, Day 16, Day 24 and Day 38 |
| Change in stool consistency using the 7-point Bristol Stool Form Scale (BSFS) between the groups |
baseline to Day 9, Day 16, Day 24 and Day 38 |
| Change in ease of Stool passage between the groups |
baseline to Day 9, Day 16, Day 24 and Day 38 |
| Change in fecal microflora using stool culture between the groups |
from baseline to Day 16, Day 24 and Day 38 |
| Change in quality of life using Quality of Life (QoL) questionnaire between the groups |
from baseline to Day 9, Day 16, Day 24 and Day 38 |
| Correlation between QoL Questionnaire and GI Transit [Colonic Geometric Center, Colonic filling at 6 hours (%) and Gastric emptying half-life (t½) (min)] between the groups |
at baseline and Day 24 |
| Assessment of safety in terms of incidence of treatment emergent adverse events |
From baseline to day 4, day 9, Day 16, Day 24 and Day 38 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group multicenter study to evaluate the effect and safety of synbiotic formulation in comparison to placebo in 90 subjects with constipation. The primary objective of this study will be to evaluate the effect of a synbiotic (probiotic and prebiotic combination) formulation on gastrointestinal parameters primarily gastrointestinal transit time (bowel habit and transit time) and improvement of abdominal symptoms (distension, bloating, flatulence, abdominal pain). |