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| Name | Class |
|---|---|
| Biohm Health, LLC | UNKNOWN |
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This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences).
Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Consists of 575 mg rice oligodextrin |
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| Active | Active Comparator | Consists of 575mg [30 billion colony forming units probiotic blend of Bifidobacterium breve 19bx, Lactobacillus acidophilus 16axg, Lacticaseibacillus rhamnosus 18fx, Saccharomyces boulardii 16mxg, and alpha amylase](streamdown:incomplete-link) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase | Dietary Supplement | A multi-strain probiotic blend |
| Measure | Description | Time Frame |
|---|---|---|
| Flatulence (gas) | Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence. | Change from baseline to 6 weeks. |
| Gastro-intestinal bloating | Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating. | Change from baseline to 6 weeks. |
| Abdominal discomfort | Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort. | Change from baseline to 6 weeks. |
| Gastrointestinal Symptom Rating Scale (GSRS) | Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems. | Change from baseline to 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency | Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools. | Change from baseline to 6 weeks. |
| Stool regularity | Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Health Survey (SF-36) | Health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status. | Change from baseline to 6 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38350481 | Derived | La Monica MB, Raub B, Lopez HL, Ziegenfuss TN. A probiotic amylase blend reduces gastrointestinal symptoms in a randomised clinical study. Benef Microbes. 2023 Oct 23;14(5):459-476. doi: 10.1163/18762891-20230043. |
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| Change from baseline to 6 weeks. |
| Constipation | Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation. | Change from baseline to 6 weeks. |
| ID | Term |
|---|---|
| D003248 | Constipation |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
| D000516 | alpha-Amylases |
| ID | Term |
|---|---|
| D000681 | Amylases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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