Terraflora Daily Care and Gastrointestinal Health | NCT07355634

Studies
Terraflora Daily Care and Gastrointestinal Health

NCT07355634

Sponsor

OvationLab

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Gastrointestinal

Interventions

Synbiotic Dietary Supplement
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2026Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Jan 2, 2026

First Submission Date that Met QC Criteria

Jan 12, 2026

First Posted Date

Jan 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Terraflora - Daily Care	Experimental		Dietary Supplement: Synbiotic Dietary Supplement
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synbiotic Dietary Supplement	Dietary Supplement	12 weeks of supplementation with Enviromedica - Terraflora Daily Care	Terraflora - Daily Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GA-Map Dysbiosis on GI360 Profile		4 weeks, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants with dysfunction on GI360 Profile		4 weeks, 12 weeks
Gastrointestinal Symptom Rating Scale	Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chris D'Adamo, Ph.D.	Contact	240-232-2103		chris@ovationlab.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OvationLab	Recruiting	Richmond	Virginia	23220	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided