Health Products for Abdominal Pain

Overseen By Susan Hewlings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of two health products on abdominal pain and overall gut health. Participants will receive either one of the two active products (GI Health Active Product 1 or GI Health Active Product 2) or a placebo (a pill with no active ingredients) to compare results. It is ideal for individuals in the U.S. who experience abdominal pain and believe they could see a 30% improvement in their condition. Participants must agree to take the product without knowing if it is the real treatment or the placebo until the study concludes.

As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve gut health.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GI Health Active Product 1 is generally well-tolerated. In studies, some participants experienced mild issues such as diarrhea, nausea, bloating, and stomach pain, but no serious problems were reported. This suggests that while some discomfort might occur, it is unlikely to be severe.

For GI Health Active Product 2, studies observed similar mild side effects, including diarrhea, nausea, bloating, and stomach pain, with no serious issues reported. This indicates that while mild discomfort might occur, the product is expected to be safe overall.

Both products appear safe based on current research, with only mild and manageable side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about GI Health Active Products 1 and 2 because they offer a fresh approach to managing abdominal pain. Unlike current treatments, which often involve antispasmodics or acid reducers, these products may target gut health directly, potentially improving the underlying gastrointestinal environment. This new method could lead to more sustainable relief with fewer side effects. Additionally, the possibility of using natural or novel compounds in these products might offer a safer alternative for those concerned about long-term medication use.

What evidence suggests that this trial's treatments could be effective for abdominal pain?

Research has shown that GI Health Active Product 1, a treatment in this trial, may help reduce belly pain. In one study, participants reported noticeable improvements in belly pain compared to those who took a placebo, especially among women.

For GI Health Active Product 2, another treatment option in this trial, studies have highlighted its potential to improve bowel habits and reduce bloating, indigestion, and stomach aches. Participants noted at least a 20% improvement in these symptoms. Both products aim to improve gut health and provide relief from common digestive issues. ^{4 6 7 8 9}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for individuals experiencing abdominal pain. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Inclusion

This section is for criteria that would disqualify me from participating.

I am pregnant, trying to become pregnant, or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

No in-person visits; all assessments are electronic

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• GI Health Active Product 1
• GI Health Active Product 2
• GI Health Product Placebo Control

Trial Overview

The study is testing two different GI Health Active Products against a placebo control to see their effects on gastrointestinal (GI) health and related outcomes. It's randomized and double-blind, meaning neither the researchers nor participants know who gets which treatment.

How Is the Trial Designed?

Group I: GI Health Active Product 2 Experimental Treatment 1 Intervention

GI Health Active Product 2

Group II: GI Health Active Product 1 Experimental Treatment 1 Intervention

GI Health Active Product 1

Group III: GI Health Product Placebo Control Placebo Group 1 Intervention

GI Health Product Placebo Control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07318077

Radicle GI Health DBG: A Study Assessing the Impact of ...

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06376695

Radicle GI Health 24: A Study of Health and Wellness ...

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 ...

3.

mdpi.com

mdpi.com/1661-3821/5/2/14?utm_campaign=releaseissue_nutraceuticalsutm_medium=emailutm_source=releaseissueutm_term=titlelink6

A Novel Direct Butyrate Generator Reduces Belly Pain in ...

Statistically significant improvements were observed in belly pain for the active ButyraGen® group compared with the placebo group, particularly in women, and ...

4.

withpower.com

withpower.com/trial/phase-gastrointestinal-disorder-2-2024-5f8eb

Health Products for Gut Health · Info for Participants

The study tests a new wellness product (Radicle GI Health Active Study Product 1.1) against a placebo to see if it improves gastrointestinal health and related ...

5.

cghjournal.org

cghjournal.org/article/S1542-3565%2824%2900254-4/fulltext

Upadacitinib Reduces Crohn's Disease Symptoms Within ...

In this analysis, rapid symptom relief occurred within 5 to 6 days of UPA treatment. Similar results were observed in a post hoc analysis of UPA ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06376695

Radicle GI Health 24: A Study of Health and Wellness ...

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11675942/

A Real-World Adverse Events Analysis from the FAERS ...

Despite their proven benefits, GLP-1 RAs are frequently associated with gastrointestinal (GI) adverse events (AEs), leading the FDA to issue ...

8.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0029201

Abdominal Pain (DBCOND0029201)

An antispasmodic used for the symptomatic treatment of stomach pain and spasms associated with irritable bowel syndrome and other gastrointestinal illnesses.

9.

journals.lww.com

journals.lww.com/ajg/fulltext/2021/06000/efficacy_and_safety_of_over_the_counter_therapies.14.aspx

Efficacy and Safety of Over-the-Counter Therapies for...

Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported. DISCUSSION: The spectrum of OTC products ...