| CTRI Number |
CTRI/2024/11/076363 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to determine the safety and Efficacy of an oral probiotic supplementation in the management of Irritable Bowel Syndrome with protein digestion. |
|
Scientific Title of Study
|
A Preliminary investigation of the safety and effectiveness of oral probiotics supplementation for management of Irritable Bowel Syndrome: A Randomized, Open label, Placebo-Arm, Comparative, Proof-Of-Science, Interventional, Proof-of-Science Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240026-MB version 1.0 08 Oct 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Prajapati |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A – 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator-Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A – 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A – 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Meteoric Biopharmaceuticals Pvt. Ltd.
9th Floor, Earth Arise, Near YMCA Club,
S.G Highway, Makarba,
Ahmedabad 380 015,
Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Meteoric Biopharmaceuticals Pvt. Ltd. |
| Address |
9th Floor, Earth Arise,
Near YMCA Club, S.G Highway, Makarba,
Ahmedabad – 380 015, Gujarat, India.
|
| 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 Vipul Prajapati |
NovoBliss Research Pvt. Limited |
Clinical trial department Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT |
7948983895
consultant@novobliss.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS– Independent Ethics Committee |
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 |
MetBroma |
Test product: Bromelain
Manufactured and marketed by:Meteoric Biopharmaceuticals Private Limited
Mode of usage:Take one capsule twice a day, after meal.
Dosage Form: Capsule Unit Dose
Storage Condition: NMT 25 degree Celsius
Route of administration: oral |
| Comparator Agent |
Placebo |
Test product: Bromelain
Manufactured and marketed by:Meteoric Biopharmaceuticals Private Limited
Mode of usage:Take one capsule twice a day, after meal.
Dosage Form: Capsule Unit Dose
Storage Condition: NMT 25 degree Celsius
Route of administration: oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The subject is an adult male or female aged between 18 to 60 years old.
2.Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month – over at least 2 months – associated with one or more of the following:
i.Related to defecation
ii.A change in frequency of stool
iii.A change in form (appearance) of stool
iv.After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
3.The subject is having refrigerator at their home for storage of test treatment.
4.The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
5.The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
6.The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
7.If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
i.Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
ii.Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
|
|
| ExclusionCriteria |
| Details |
1.The subject has a history of diagnosis of either hypertension, diabetes, or liver disease
2.The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant
3.The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
4.The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
5.The subject has a history of alcohol abuse
6.The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
7.The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
8.The subject has other significant gastrointestinal diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease).
9.The subject has any condition that, in the investigator judgment, would compromise the subject safety or study integrity.
10.The subject has abnormal baseline Haemoglobin, Complete Blood Count, Urine Routine/Microscopy, or Stool Routine/Microscopy results that suggest a different pathology than irritable bowel syndrome. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio, total serum protein and prealbumin levels.
2.Evaluate the effect of the test treatment in terms of change in the lifestyle using the Scoring and Gradation for assessment of Lifestyle.
3.Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome
|
Day 01 for baseline, and post-dose on Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC), Biochemical tests, and Urinalysis |
Day 01 for baseline, and post-dose on Day 30. |
| Evaluate the effect of the test treatment in terms of change in CRP and IL-6 levels. |
Assessment of the effectiveness of the test treatment in terms of change in CRP and IL-6 levels on Day 01 (before administration) for baseline, and post-dose on Day 30. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome. A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study. Subjects shall be instructed to visit the facility for the following scheduled visits: Visit 01 [Within 30 days]: Screening, Blood Parameter Assessment Visit 02 [Day 01]: Enrolment, Evaluations, Treatment Dispensing Visit 03 [Day 15 (±2 days)]: Telephonic follow-up. Visit 04 [Day 30 (±2 days)]: Treatment End, Final Evaluations |