Gastrointestinal
Conditions
Brief summary
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.
Interventions
12 weeks of supplementation with Enviromedica - Terraflora Daily Care
Placebo capsule
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adult males or females age ≥ 25 years 2. Ability to read and speak English 3. Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
Exclusion criteria
1. Daily use within the past month of any probiotic or prebiotic supplement 2. Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis 3. Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications 4. Current daily tobacco smoker 5. Known allergies to any substance in the study products 6. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks 7. Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol 8. Current participation in another clinical trial 9. Participants unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GA-Map Dysbiosis on GI360 Profile | 4 weeks, 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with dysfunction on GI360 Profile | 4 weeks, 12 weeks | — |
| Gastrointestinal Symptom Rating Scale | 4 weeks, 12 weeks | Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms. |
Countries
United States