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NCT Number: NCT07355634

Terraflora Daily Care and Gastrointestinal Health

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.

Recruiting

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Key information

Conditions

Gastrointestinal

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OvationLab

Richmond, Virginia, 23220, United States

Location status: Recruiting

Location contact

Study Administration

CONTACT

[email protected]

‪(240) 232-2103‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males or females age ≥ 25 years
  • Ability to read and speak English
  • Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)

Exclusion criteria

  • Daily use within the past month of any probiotic or prebiotic supplement
  • Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
  • Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
  • Current daily tobacco smoker
  • Known allergies to any substance in the study products
  • Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
  • Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol
  • Current participation in another clinical trial
  • Participants unable to provide consent

Treatment and study plan

Synbiotic Dietary Supplement

Dietary Supplement

12 weeks of supplementation with Enviromedica - Terraflora Daily Care

Placebo

Dietary Supplement

Placebo capsule

Primary outcomes

  1. GA-Map Dysbiosis on GI360 Profile

    Time frame: 4 weeks, 12 weeks

Secondary outcomes

  1. Percentage of participants with dysfunction on GI360 Profile

    Time frame: 4 weeks, 12 weeks

  2. Gastrointestinal Symptom Rating Scale

    Time frame: 4 weeks, 12 weeks

    Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Chris D'Adamo, Ph.D.

CONTACT

[email protected]

240-232-2103

Sponsors and collaborators

Lead sponsor

OvationLab

Network

Registry information

Official study title

A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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