Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

NCT06376695 | Completed

• 1 other identifier: RADX-P-2407
• Study Type: interventional
• Target: 4,607
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Conditions

Abdominal Pain; GI Disorders; Digestion

Outcome Measures

Primary Outcomes (6)

• Change in GI (Gastrointestinal) Health (1)

  Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)

  6 weeks

• Change in GI (Gastrointestinal) Health (2)

  Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)

  6 weeks

• Change in GI (Gastrointestinal) Health (3)

  Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation)

  6 weeks

• Change in GI (Gastrointestinal) Health (4)

  Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea)

  6 weeks

• Change in GI (Gastrointestinal) Health (5)

  Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)

  6 weeks

• Change in GI (Gastrointestinal) Health (6)

  Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)

  6 weeks

Secondary Outcomes (12)

• Change in feelings of anxiety

  6 weeks

• Change in GI-related Quality of Life (QOL)

  6 weeks

• Change in mood (emotional distress-depression)

  6 weeks

• Minimal clinically important difference (MCID) in GI Health (1)

  6 weeks

• Minimal clinically important difference (MCID) in GI Health (2)

  6 weeks

Other Outcomes (1)

• Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

  6 weeks

Study Arms (18)

Placebo Control 1.1

PLACEBO COMPARATOR

GI Health Product Form 1 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

GI Health Product Form 1 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage

Placebo Control 2

PLACEBO COMPARATOR

GI Health Product Form 2 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

GI Health Product Form 2 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage

Placebo Control 3

PLACEBO COMPARATOR

GI Health Product Form 3 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 3

Active Product 3.1

EXPERIMENTAL

GI Health Product Form 3 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage

Placebo Control 4

PLACEBO COMPARATOR

GI Health Product Form 4 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 4

Active Product 4.1

EXPERIMENTAL

GI Health Product Form 4 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 4.1 Usage

Placebo Control 5

PLACEBO COMPARATOR

GI Health Product Form 5 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 5

Active Product 5.1

EXPERIMENTAL

GI Health Product Form 5 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 5.1 Usage

Placebo Control 7.1.0

PLACEBO COMPARATOR

GI Health Product Form 7.1- control

Dietary Supplement: Radicle GI Health Placebo Control Form 7

Active Product 7.1.1

EXPERIMENTAL

GI Health Product Form 7.1 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 7.1 Usage

Placebo Control 7.2.0

PLACEBO COMPARATOR

GI Health Product Form 7.2 - control

Dietary Supplement: Radicle GI Health Placebo Control 7.2

Active Product 7.2.1

EXPERIMENTAL

GI Health Product Form 7.2 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 7.2.1 Usage

Placebo Control 7.3.0

PLACEBO COMPARATOR

GI Health Product Form 7.3 - control

Dietary Supplement: Radicle GI Health Placebo Control 7.3.0

Active Product 7.3.1

EXPERIMENTAL

GI Health Product Form 7.3 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 7.3.1 Usage

Placebo Control 7.4.0

PLACEBO COMPARATOR

GI Health Product Form 7.4 - control

Dietary Supplement: Radicle GI Health Placebo Control 7.4.0

Active Product 7.4.1

EXPERIMENTAL

GI Health Product Form 7.4 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 7.4.1 Usage

Interventions

Radicle GI Health Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1.1

Radicle GI Health Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Radicle GI Health Placebo Control Form 2 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2

Radicle GI Health Active Study Product 2.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1

Radicle GI Health Placebo Control Form 3 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.

Placebo Control 3

Radicle GI Health Active Study Product 3.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.

Active Product 3.1

Radicle GI Health Placebo Control Form 4 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.

Placebo Control 4

Radicle GI Health Active Study Product 4.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 4.1 as directed for a period of 6 weeks.

Active Product 4.1

Radicle GI Health Placebo Control Form 5 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.

Placebo Control 5

Radicle GI Health Active Study Product 5.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 5.1 as directed for a period of 6 weeks.

Active Product 5.1

Radicle GI Health Placebo Control Form 7 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 7 as directed for a period of 6 weeks.

Placebo Control 7.1.0

Radicle GI Health Active Study Product 7.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 7.1 as directed for a period of 6 weeks.

Active Product 7.1.1

Radicle GI Health Placebo Control 7.2 DIETARY_SUPPLEMENT

Participants will use their Placebo Control 7.2 as directed for a period of 6 weeks.

Placebo Control 7.2.0

Radicle GI Health Active Study Product 7.2.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 7.2.1 as directed for a period of 6 weeks.

Active Product 7.2.1

Radicle GI Health Placebo Control 7.3.0 DIETARY_SUPPLEMENT

Participants will use their Placebo Control 7.3 as directed for a period of 6 weeks.

Placebo Control 7.3.0

Radicle GI Health Active Study Product 7.3.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 7.3.1 as directed for a period of 6 weeks.

Active Product 7.3.1

Radicle GI Health Placebo Control 7.4.0 DIETARY_SUPPLEMENT

Participants will use their Placebo Control 7.4 as directed for a period of 6 weeks.

Placebo Control 7.4.0

Radicle GI Health Active Study Product 7.4.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 7.4.1 as directed for a period of 6 weeks.

Active Product 7.4.1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains
• Has the opportunity for at least 20% improvement in their primary health outcome
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

You may not qualify if:

• Report being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study product
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Abdominal Pain; Digestive System Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender at birth then randomized to one of the study arms

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 19, 2024
• Study Start: April 29, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)