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Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic dietary supplement | Experimental | Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:
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| Placebo | Placebo Comparator | The placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic dietary supplement (Trenev Trio®) | Dietary Supplement | Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of self-reported bloating | Likert scale | Study end (6 weeks from baseline) |
| Severity of self-reported gas | Likert scale | Study end (6 weeks from baseline) |
| Severity of self-reported indigestion | Likert scale | Study end (6 weeks from baseline) |
| Severity of self-reported abdominal pain | Likert scale | Study end (6 weeks from baseline) |
| Severity of self-reported defecation irregularity | Likert scale | Study end (6 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of self-reported bloating | Likert scale | Study end (6 weeks from baseline) |
| Frequency of self-reported gas | Likert scale | Study end (6 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Study end (6 weeks from baseline) | |
| Gastrointestinal Quality of Life Index | Study end (6 weeks from baseline) | |
| Bristol Stool Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris D'Adamo, PhD | University of Maryland, College Park | Principal Investigator |
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| ID | Term |
|---|---|
| D009085 | Mucopolysaccharidosis IV |
| D004415 | Dyspepsia |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| placebo | Dietary Supplement |
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| Frequency of self-reported indigestion | Likert scale | Study end (6 weeks from baseline) |
| Frequency of self-reported abdominal pain | Likert scale | Study end (6 weeks from baseline) |
| Frequency of self-reported defecation irregularity | Likert scale | Study end (6 weeks from baseline) |
| Study end (6 weeks from baseline) |
| Rescue medication usage | Study end (6 weeks from baseline) |
| Adequate relief | "In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?" | Study end (6 weeks from baseline) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |