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For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.
The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.
Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.
This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 1 | Experimental | Probiotic 1: A dietary probiotic supplement which contains Bifidobacterium lactis. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. |
|
| Probiotic 2 | Experimental | Probiotic 2: A dietary probiotic supplement which contains Lactobacillus acidophilus. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. |
|
| Placebo | Placebo Comparator | The Placebo contains MCC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic 1 | Dietary Supplement | The product under investigation is a unique probiotic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal pain severity | The change at Day 42 will be assessed by subject dairy. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal pain severity | The change at Day 21 will be assessed by subject dairy | Day 21 |
| Change in IBS symptoms | The change at Day 42 will be compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalini Srivastava, M.D. | Vedic Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex Gastro Clinic | Ahmedabad | Gujarat | 380013 | India | ||
| Gastrocare & Liver Clinic |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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Apart from the participant and Investigator, the study team is also blinded.
| Probiotic 2 | Dietary Supplement | The product under investigation is a unique probiotic. |
|
|
| Placebo | Other | Microcrystalline Cellulose |
|
| Day 42 |
| Change in stool consistency | The change at Day 42 will be compared to baseline by specific questionnaire | Day 42 |
| Change in Quality of Life | The change at Day 42 will be compared to baseline by specific questionnaire | Day 42 |
| Change in daily number of stools | The change at Day 42 will be compared to baseline | Day 42 |
| Ahmedabad |
| Gujarat |
| 380015 |
| India |
| The Gut Clinic | Mumbai | Maharashtra | 400012 | India |
| Vazifdar Clinic | Mumbai | Maharashtra | 400055 | India |
| Stress Test Clinic | Mumbai | Maharashtra | 400059 | India |
| Shantaee Nursing Home | Mumbai | Maharashtra | 400067 | India |
| Dr Sanjeev Khanna's Clinic | Mumbai | Maharashtra | 400069 | India |
| Ameeta Nursing home | Mumbai | Maharashtra | 400071 | India |
| Lancelot Kidney and GI Center | Mumbai | Maharashtra | 400092 | India |
| Kshirsagar Nursing Home | Mumbai | Maharashtra | 400602 | India |
| Samarth Clinic | Navi Mumbai | Maharashtra | 400703 | India |
| Sampada Hospital | Thane | Maharashtra | 400601 | India |