NCT07355634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

January 2, 2026

Last Update Submit

May 5, 2026

Conditions

Gastrointestinal

Outcome Measures

Primary Outcomes (1)

  • GA-Map Dysbiosis on GI360 Profile

    4 weeks, 12 weeks

Secondary Outcomes (2)

  • Percentage of participants with dysfunction on GI360 Profile

    4 weeks, 12 weeks

  • Gastrointestinal Symptom Rating Scale

    4 weeks, 12 weeks

Study Arms (2)

Terraflora - Daily Care

EXPERIMENTAL
Dietary Supplement: Synbiotic Dietary Supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo capsule

Placebo
Synbiotic Dietary SupplementDIETARY_SUPPLEMENT

12 weeks of supplementation with Enviromedica - Terraflora Daily Care

Terraflora - Daily Care

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OvationLab

Richmond, Virginia, 23220, United States

RECRUITING

Central Study Contacts

Chris D'Adamo, Ph.D.

CONTACT

240-232-2103chris@ovationlab.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 21, 2026

Study Start

January 12, 2026

Primary Completion

June 1, 2026

Study Completion

September 1, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)