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| ID | Type | Description | Link |
|---|---|---|---|
| IRB201900115 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Lallemand Bio-Ingredients | OTHER |
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Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.
There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.
Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.
Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro studies, of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve the heartburn symptom severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastro-AD® Group | Experimental | The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents. |
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| Placebo Group | Placebo Comparator | Participants in this arm will take a sachet containing maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastro-AD® | Other | The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets. Content: 1 g of Gastro-AD® powder per sachet + flavoring agents. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of heartburn symptoms | Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort | 5 minutes, 15 minutes, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. | Baseline; Week 4; Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy J Dahl, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Science and Human Nutrition Department | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a double-blind study; the sponsor representative involved in the study, the investigator, the participants or site personnel involved in participant management or outcome assessment will remain blinded. Blinding to intervention will be used to reduce bias during data collection and evaluation of outcomes. At the investigational site, the randomization codes will remain secure at all times, but may be accessed in the event of an emergency.
| Placebo | Other | The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets. |
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| Change in Quality of Life (GERD-QOL) | The GERD-QOL is disease-specific instrument of 16 items combined into domains. | Baseline; Week 4; Week 5 |
| Heartburn event frequency | Heartburn events per period | Baseline; Week 4; Week 5 |