| CTRI Number |
CTRI/2024/08/071819 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test product in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation, gut immunity). |
|
Scientific Title of Study
|
A prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation, and gut immunity). |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NB240019-MB Version 2.0 05 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 – 382421, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@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 – 382421, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| 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 – 382421, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| 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 |
Meteoric Biopharmaceuticals Pvt. Ltd.
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
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical Trial
department, A - 206,
2nd Floor, Shaligram
Lakeview Business
Complex, Nr.
Vaishnodevi Circle,
Khoraj, Gandhinagar –
382421, Gujarat – India
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT |
9909013286
dr.nayan@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 |
| Healthy Human Volunteers |
Healthy Human Volunteers having symptoms of gut dysbiosis |
| Patients |
(1) ICD-10 Condition: K599||Functional intestinal disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MetProUltima |
Dosage Form- Slow Release Capsule.
Rout Of Administration- Oral
Frequency- Twice a day.
Mode of Usage- Take one capsule after each meal, twice daily.
Duration: 90 days
Dose : Twice a Day. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 65 years (both inclusive) at the time of consent.
2) Sex: Healthy males and healthy non-pregnant/non-lactating females.
3) Females of childbearing potential must have a self-reported negative pregnancy test.
4) Subject should have refrigerator at their home for storage of test product.
5) Subjects having history of falling sick frequently in two months.
6) Subjects having elevated levels of CRP and IL-6 with symptoms of gut dysbiosis.
7) Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
8) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
9) Subjects are willing to give written informed consent and are willing to come for regular follow-up.
10) Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
11) Subject who has not participated in a similar investigation in the past three months.
12) Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1 Subject with suspected or proved organic causes of constipation, such as Hirschsprung disease, hypothyroidism, or structural anomalies of the anal canal.
2 Subject with present condition of allergic response to any probiotic product.
3 Subject under chronic medication aspirin based products, anti inflammatories, anti histamines, corticotherapy that might influence the outcome of the study.
4 Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
5 History of alcohol or drug addiction.
6 Subjects with a history of major gastrointestinal complications such as Crohn disease, ulcer, cancer, ulcerative colitis.
7 Subjects who have self reported immuno compromised HIV positive, on anti rejection medication, rheumatoid arthritis.
8 Pregnant or breastfeeding or planning to become pregnant during the study period.
9 Subjects participating in other similar product or therapeutic trials within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product in terms of:
1.Change in stool consistency based on the Bristol Stool Criteria.
2.Change in faecal microbiota using 16s Metagenome sequencing.
16s Metagenome sequencing from baseline and after usage of the test product
3. Frequency of sensation of defecation, bloating, nausea, altered bowel habit, digestion issues, aching joints, chronic fatigue, constipation, diarrhoea.
|
1.On baseline Day 1, and after usage of the test product on Day 45 and on Day 90 evaluated by the physician.
2.On Day 1, and on Day 90.
3.On Day 1, Day 45 and on Day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effectiveness of the test product in terms of change in Biomarkers such as CRP and IL-6 from baseline and after usage of the test product. |
After usage of test products on Day 01 and on Day 90. |
| To assess the effectiveness of the test product in terms of subject perception questionnaire from baseline before and after usage of the test product. |
Before usage of test product on Day 01 and after usage of test product on Day 45 and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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="3"
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
|
A prospective, open-label, single-arm, proof of science, clinical safety, and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heartburn, bloating, constipation, gut immunity). Maximum 14 subjects will be enrolled and 12 subjects will complete the study. Duration will be of approximately 3 months which includes 3 visits. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, Visit 02 (Day 45): Treatment usage period, Evaluations, Visit 03 (Day 90 ): Treatment usage period, Evaluations and End of Study.
|