| CTRI Number |
CTRI/2022/09/045755 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to establish the effect of Lactiliq-TM syrup in patients with chronic idiopathic constipation. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Active-Controlled, 4-week Parallel Group
Study to Evaluate the Efficacy and Safety of Lactitol and Probiotic Bacillus Coagulans SC208 in patients with Chronic Idiopathic Constipation. |
| Trial Acronym |
Lactiliq-TM Syrup |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLSPL/SC208-L/01/2022 Protocol V 1.0 Dated 21 Jun 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Shivnitwar |
| Designation |
Principal Investigator |
| Affiliation |
Lifepoint Multispeciality Hospital |
| Address |
Lifepoint Multispeciality Hospital,
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji,
Wakad, Pune 411057,
Maharashtra,
India
Pune
MAHARASHTRA
411057
India |
| Phone |
8999285166 |
| Fax |
020-66434300 |
| Email |
sachinshivnitwar94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh H Divekar |
| Designation |
Vice President - Clinical Operations and Biometrics |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
Kalpataru Prime,1st floor, Unit Nos. 3 & 4, Plot no. D-3, Road no. 16, Wagle Industrial Estate, Thane (W) - 400 604, Maharashtra, India
Thane
MAHARASHTRA
400604
India |
| Phone |
02261088000 |
| Fax |
02261088081 |
| Email |
ganesh.divekar@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt. Ltd. |
| Address |
Synergia Life Sciences Pvt. Ltd.
1503, Universal Majestic, P. L. Lokhande Marg, Ghatkopar – Mankhurd Link Road, Govandi, Mumbai – 400 043, INDIA
Mumbai
MAHARASHTRA
400043
India |
| Phone |
91-9930241802 |
| Fax |
912262669600 |
| Email |
ssaj@novozymes.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt. Ltd.,
1503, Universal Majestic, P. L. Lokhande Marg, Ghatkopar – Mankhurd Link Road, Govandi, Mumbai – 400 043, INDIA |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
1503,Universal Majestic, P. L. Lokhande Marg,
Ghatkopar –Mankhurd Link Road,
Govandi, Mumbai – 400 043, Maharashtra |
| Type of Sponsor |
Other [Neutraceuticals] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Siro Clinpharm Pvt Ltd |
Kalpataru Prime, 1st floor, Unit Nos. 3 & 4, Plot no. D-3, Road no. 16, Wagle Industrial Estate, Thane (W) - 400 604, Maharashtra, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sachin Shivnitwar |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji,
Wakad, Pune 411057, Maharashtra
Pune
MAHARASHTRA |
8999285166
sachinshivnitwar94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifepoint Research- Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LactiliqTM Syrup (Lactitol and Bascillus Coagulance SC208)
|
Patients will receive 15 ml Lactitol Syrup once daily for 4 weeks. |
| Comparator Agent |
Lactitol Syrup |
Patients will receive 15 ml Lactitol Syrup once daily for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients both males and females, between 18-65 years of
age.
2. Patients who are known cases of Chronic Idiopathic
Constipation (CIC) defined by Rome III diagnostic
criteria
Rome III defines functional constipation or chronic
idiopathic constipation as the presence of two or more of
the following for more than 6 months:
a. Straining during at least 25% of defecations.
b. Lumpy or hard stools in at least 25% of
defecations.
c. Sensation of incomplete evacuation for at least
25% of defecations.
d. Sensation of anorectal obstruction/blockage for
at least 25% of defecations.
e. Manual maneuvers to facilitate at least 25% of
defecations (e.g., digital evacuation, support of
the pelvic floor).
f. Fewer than three defecations per week.
3. Patients on stable medications (past 3 months) in case suffering from Diabetes Mellitus Type II.
4. Patients willing to abide by study procedures and provide voluntary written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone major abdominal surgery.
2. Patients with concomitant diseases such as
Gastrointestinal diseases and/or medical or psychiatric illness.
3. Patients with family history of peptic ulcer, colorectal cancer or IBD.
4. Patients with a documented history of slow colonic transit.
5. Patients with abnormal laboratory data ( i.e. with liver enzymes (ALT and AST) more than 3 times ULN1 and/or bilirubin more than 1.5 times ULN1).
6. Patients with history of hypothyroidism or abnormal thyroid function.
7. Patients with history of renal impairment or abnormal renal function test ( i.e. Serum creatinine more than 2 times ULN1).
8. Any other laboratory value abnormality considered clinically significant by the Investigator.
9. Patients who participated in any clinical trial in the past 90 days.
10. Patients who have received any probiotic formulation in the past 30 days.
11. Patients with known or expected hypersensitivity to any of the active substances or excipients.
12. Patients who are pregnant or lactating.
13. Patients who are allergic or atopic to any of the ingredients of the study medication.
14. Patients suffering from any other medical condition in opinion of the Investigator that may put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patients participation in the study.
15. Patients with use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication.
16. Disease assessment score of more than or equal to 15 with constipation scoring system. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Treatment success (defined as 3 or more spontaneous
stools per week). |
Day 29. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) Treatment success (defined as 3 or more spontaneous
stools per week) at Day 8, 15
B) Change in category according to Bristol scale for stool passage from baseline to Day 8, 15 and 29 in:
i) Stool frequency (Constipation Scoring System [CSS] scale)
ii) Difficulty degree of defecation-sensation of
incomplete evacuation (Constipation Scoring System
[CSS] scale).
iii) Defecation pain (Constipation Scoring System [CSS] scale).
iv) Abdominal Pain (Constipation Scoring System
[CSS] scale).
C) Change from baseline to Day 8, 15 and 29 for:
i) Evaluation Questionnaire in patients with constipation
ii) Abdominal gas
iii) Bloating |
Day 8, 15 & 29 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
31/10/2022 |
| Date of Study Completion (India) |
09/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, Active control, 4 week
parallel group, to evaluate the safety and efficacy of Lactitol and Probiotic
Bacillus Coagulans SC208 15 ml daily or Lactitol 15 ml daily for 28 Days in 40
(20 patients with each arm) patients with Chronic Idiopathic Constipation that
will be conducted in approximately 2 centers in India. The primary outcome
measures Treatment success (defined as 3 or more spontaneous stools per week) at day 29. The secondary outcomes will be
treatment success at day 29, Change in Bristol scale at day 8, 15 & 29.
Change in gut microbiome composition from baseline to Day 29 (through the faecal
microbiome analysis). |