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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying whether detergents in products like toothpaste can make the esophagus lining leaky and cause allergic reactions. It focuses on people who might have allergic inflammation in their esophagus due to these detergents.

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.

Is the treatment generally safe for humans?

Most people exposed to liquid laundry detergent capsules have no symptoms or only minor issues, but some can experience serious problems like breathing difficulties or eye injuries. Safety measures have been put in place to reduce risks, especially for children. ^{1 2 3 4 5}

Research Team

Benjamin Wright, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I have a diagnosed digestive or connective tissue condition.

Pregnancy

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

The impact of an international initiative on exposures to liquid laundry detergent capsules reported to the United Kingdom National Poisons Information Service between 2008 and 2015. [2017]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety data sheets as an information pathway on hazards of occupationally used cleaning agents. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of historic in vivo data to characterise the emetic properties of liquid cleaning products and provide a framework for the development of an in silico predictive algorithm. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Referral of pediatric laundry detergent pack exposure reported to poison centers. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Hazard of household cleaning products: a study undertaken by the UK National Poisons Information Service. [2016]