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This is a single-arm, open-label clinical trial involving 100 participants who will undergo a total participation period of 12 weeks.
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take PhytoMulti® Multivitamin at a fixed dose of 2 tablets per day and UltraFlora® Balance Probiotic at a fixed dose of 1 capsule per day, both administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions at fixed timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamin and a Probiotic | Dietary Supplement | The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of the study products (PhytoMulti® Multivitamin, 2 tablets/day and UltraFlora® Balance Probiotic, 1 capsule/day) are taken daily with breakfast |
| Measure | Description | Time Frame |
|---|---|---|
| IBS- SSS | To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS) | From enrollment to the end of treatment at 12 weeks (90 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irfan Qureshi, MD | Contact | +1 800-843-9660 | trials@metagenics.com |
| Name | Affiliation | Role |
|---|---|---|
| Mieke Van Den Driessche, PhD | Metagenics, Inc. | Study Director |
| Irfan Qureshi, MD | Metagenics, Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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