Terraflora Daily Care and Gastrointestinal Health

OvationLab

Status: Not yet enrolling

Conditions: Gastrointestinal

Treatments: Dietary Supplement: Synbiotic Dietary Supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07355634

ENV-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Terraflora - Daily Care

Experimental group

Treatment:

Dietary Supplement: Synbiotic Dietary Supplement

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo