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| Name | Class |
|---|---|
| Meteoric Biopharmaceuticals Pvt. Ltd. | INDUSTRY |
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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.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MetBroma | Experimental | Active Ingredients: Bromelain Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day |
|
| Placebo | Placebo Comparator | Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetBroma | Other | Mode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Albumin/Globulin ratio | Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio | Baseline before and 6-8 hours post-dose on Day 01 and Day 30 |
| change in total serum protein | Evaluate the effect of the test treatment in terms of change in total serum protein | Baseline before and 6-8 hours post-dose on Day 01 and Day 30 |
| change in prealbumin levels | Evaluate the effect of the test treatment in terms of change in prealbumin levels. | Baseline before and 6-8 hours post-dose on Day 01 and Day 30 |
| Change in the lifestyle using the Scoring and Gradation | Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation. Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle<25 | Day 01 (before administration) for baseline, and post-dose on Day 30. |
| Scoring and Gradation of symptoms of irritable bowel syndrome | Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome. Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged<25% | Day 01 (before administration) for baseline, and post-dose on Day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of safety laboratory tests including Complete Blood Count (CBC) | Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC) | on Day 30 |
| Performance of safety laboratory tests including Biochemical tests |
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Inclusion Criteria:
The subject is an adult male or female aged between 18 to 60 years old.
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
The subject is having refrigerator at their home for storage of test treatment.
The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maheshvari N Patel | Contact | 09909013236 | maheshvari@novobliss.in | |
| Sheetal J Khandwala | Contact | bd@novobliss.in |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Nayan K Patel | NovoBliss Research Pvt Ltd | Principal Investigator |
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Evaluate the safety of test treatment through the performance of safety laboratory tests including Biochemical tests |
| on Day 30 |
| Performance of safety laboratory tests including Urinalysis | Evaluate the safety of test treatment through the performance of safety laboratory tests including Urinalysis | on Day 30 |
| Assessment of the effectiveness of the test treatment in terms of change in CRP levels | CRP will be evaluated by Lab Parameters | on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days). |
| Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels | IL-6 will be evaluated by Lab Parameters | On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days). |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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