Household Detergents and Eosinophilic Esophagitis

Overseen By Karalyn Folmes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Esophageal disease, Dysphagia, IBS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether detergents in everyday products like toothpaste make the esophagus leaky and cause allergic swelling. Participants will use Colgate toothpaste, and doctors will assess changes in the esophagus. The trial seeks healthy volunteers who can swallow pills and have not experienced esophageal issues such as heartburn or difficulty swallowing. As an unphased study, this trial offers volunteers the opportunity to contribute to important research on everyday products and their effects on health.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must avoid using toothpaste with SLS (a common detergent) for 2 weeks before the study.

What prior data suggests that this toothpaste detergent is safe for use in this study?

Research shows that some ingredients in products like Colgate toothpaste might affect the esophagus, the tube that carries food from the mouth to the stomach. Studies have found that Sodium Dodecyl Sulfate (SDS), a common ingredient, can weaken the esophagus lining, leading to more irritation and swelling. This is a concern for people with conditions like eosinophilic esophagitis.

However, these findings specifically address how the ingredient affects the esophagus, not the overall safety of daily use. Colgate toothpaste is widely used and generally considered safe for most people. For those with specific sensitivities or conditions like eosinophilic esophagitis, these findings suggest potential risks with certain ingredients.

Before joining a trial, consult a healthcare provider to understand how these findings might relate to your health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testing household detergents, specifically Colgate toothpaste, in relation to Eosinophilic Esophagitis (EoE) because of its unique approach to understanding this condition. Unlike traditional treatments for EoE, which often involve dietary changes or medications like proton pump inhibitors and corticosteroids, this trial focuses on the potential role of common household products in triggering or exacerbating symptoms. By using an esophageal string test combined with high-resolution esophageal manometry, researchers aim to uncover how certain toothpaste detergents might impact the esophagus. This innovative angle could open up new pathways for managing EoE by addressing environmental factors that have previously gone unconsidered.

What evidence suggests that toothpaste detergents are effective for testing Eosinophilic Esophagitis?

Research has shown that certain ingredients in products like Colgate toothpaste might affect the esophagus, the tube connecting the mouth to the stomach. These ingredients can weaken the esophagus's protective lining, making it more "leaky." This can increase a protein called IL-33, linked to inflammation, and cause a type of allergic reaction in the tissue. Studies have found that this can lead to allergic inflammation in the esophagus. This trial will investigate the potential involvement of toothpaste ingredients in conditions like eosinophilic esophagitis, an allergic condition affecting the esophagus. Participants will undergo testing before and after using Colgate toothpaste to assess its effects. ^{1 4 6 7 8}

Who Is on the Research Team?

Benjamin Wright, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who can swallow pills. It's not for those with a history of esophageal diseases, swallowing difficulties, chronic abdominal issues, certain digestive disorders, gelatin allergies, recent use of SLS toothpaste or those who are pregnant.

Inclusion Criteria

Normal, healthy volunteers

I can swallow pills.

Exclusion Criteria

Use of a toothpaste containing SLS within 2 weeks of the study

Pregnancy

I have a diagnosed digestive or connective tissue condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo esophageal string test and high resolution esophageal manometry, followed by brushing teeth with Colgate toothpaste

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in mucosal impedance and IL-33 levels after exposure

1 hour

What Are the Treatments Tested in This Trial?

Interventions

• Colgate

Trial Overview The study investigates if detergents like those in Colgate toothpaste contribute to allergic inflammation by making the esophagus lining leaky. Participants will undergo an Esophageal String Test and High Resolution Esophageal Manometry.

How Is the Trial Designed?

Group I: Toothpaste detergents with Eosinophilic Esophagitis Testing Experimental Treatment 3 Interventions

Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9797443/

Detergent exposure induces epithelial barrier dysfunction ... Exposure to SDS decreases esophageal barrier integrity, stimulates IL-33 production, and promotes epithelial hyperplasia and tissue eosinophilia.

2. withpower.com withpower.com/trial/phase-eosinophilic-esophagitis-7-2022-9302e

Household Detergents and Eosinophilic Esophagitis Trial Overview The study investigates if detergents like those in Colgate toothpaste contribute to allergic inflammation by making the esophagus lining leaky.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05482256?cond=Esophagitis&aggFilters=status:act&viewType=Table&rank=8

A Study of Detergents in the Pathogenesis of Eosinophilic ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. researchgate.net researchgate.net/publication/358334498_Oral_detergent_exposure_elicits_eosinophilic_inflammation_in_the_esophagus

Oral detergent exposure elicits eosinophilic inflammation in ... Data on secular trends and outcomes of eosinophilic esophagitis (EE) are scarce. We performed a population-based study to assess the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9473155/

Technical review on the management of eosinophilic ... The primary outcome for all of the interventions for this report was achieving <15 eos/hpf except for esophageal dilation. EoE has traditionally been ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/all.15457

Detergent exposure induces epithelial barrier dysfunction ... Exposure to SDS decreases esophageal barrier integrity, stimulates IL-33 production, and promotes epithelial hyperplasia and tissue eosinophilia.

7. annallergy.org annallergy.org/article/S1081-1206(25)00185-1/pdf

TaggedAPTARAFigure TaggedAPTARAEnd Colgate toothpaste material safety data sheet. Accessed April 7, 2025 ... eosinophilic esophagitis and immunotherapy. Immunol Allergy Clin North Am ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35899466/

Detergent exposure induces epithelial barrier dysfunction and ... Conclusion: Exposure to SDS decreases esophageal barrier integrity, stimulates IL-33 production, and promotes epithelial hyperplasia and tissue eosinophilia.