Eosinophilic EsophagitisNCT05482256
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
A study testing Esophageal String Test (EST), Colgate and High Resolution Esophageal Manometry (HREM) in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Esophageal String Test (EST), Colgate and High Resolution Esophageal Manometry (HREM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy volunteers.
- Able to swallow pills.
Who cannot join
- Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.
- History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.
- Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.
- Gelatin allergy.
- Use of a toothpaste containing SLS within 2 weeks of the study.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Esophageal String Test (EST), Colgate, High Resolution Esophageal Manometry (HREM)
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal String Test (EST)Diagnostic test
Also called EnteroTracker
Non-invasive, FDA-registered sampling method to evaluate eosinophilic inflammation in the esophagus. The EST is performed by having an individual swallow a capsule attached to a string which captures secretions from the esophagus. The end of the string is taped to the cheek and the capsule is swallowed with water. After 1 hour, the EST will be removed, and the string will be processed for laboratory analysis.
ColgateOther
2 grams of toothpaste (pea sized amount) for 2 minutes
High Resolution Esophageal Manometry (HREM)Diagnostic test
Thin flexible tube with sensors placed in the nose and swallowed for esophagus placement to conduct reading regarding the lining of the esophagus taken for approximately 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste detergents with Eosinophilic Esophagitis Testing | Experimental | Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste. Receives: Diagnostic Test: Esophageal String Test (EST); Other: Colgate; Diagnostic Test: High Resolution Esophageal Manometry (HREM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mucosal impedance 15 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Measured: Baseline, 15 minutes after teeth brushing
Secondary outcomes (4)
Change in Mucosal impedance 30 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Measured: Baseline, 30 minutes after teeth brushing
Change in Mucosal impedance 45 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Measured: Baseline, 45 minutes after teeth brushing
Change in Mucosal impedance 60 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Measured: Baseline, 60 minutes after teeth brushing
Change in IL-33 levels
Measured from esophageal string test eluates
Measured: Baseline, approximately 60 minutes after teeth brushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start12 Sep 2022
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin L. Wright, Mayo Clinic
- Investigators
- Benjamin Wright, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482256
- Sponsor's protocol ID
- 22-003963
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2022
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05482256
- Acronym / sponsor ID
- 22-003963
- Conditions
- Eosinophilic Esophagitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toothpaste detergents with Eosinophilic Esophagitis Testing | Experimental | Diagnostic Test: Esophageal String Test (EST), Other: Colgate, Diagnostic Test: High Resolution Esophageal Manometry (HREM)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal, healthy volunteers.
- Able to swallow pills.
Key exclusion criteria (6 listed)
- Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.
- History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.
- Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.
- Gelatin allergy.
- Use of a toothpaste containing SLS within 2 weeks of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal String Test (EST)Also: EnteroTrackerNon-invasive, FDA-registered sampling method to evaluate eosinophilic inflammation in the esophagus. The EST is performed by having an individual swallow a capsule attached to a string which captures secretions from the esophagus. The end of the string is taped to the cheek and the capsule is swallowed with water. After 1 hour, the EST will be removed, and the string will be processed for laboratory analysis. | Diagnostic test | Toothpaste detergents with Eosinophilic Esophagitis Testing |
| Colgate2 grams of toothpaste (pea sized amount) for 2 minutes | Other | Toothpaste detergents with Eosinophilic Esophagitis Testing |
| High Resolution Esophageal Manometry (HREM)Thin flexible tube with sensors placed in the nose and swallowed for esophagus placement to conduct reading regarding the lining of the esophagus taken for approximately 10 minutes | Diagnostic test | Toothpaste detergents with Eosinophilic Esophagitis Testing |
Primary outcome
Change in Mucosal impedance 15 minutes after exposure
Time frame: Baseline, 15 minutes after teeth brushing
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
4 secondary outcomes
Change in Mucosal impedance 30 minutes after exposure
Time frame: Baseline, 30 minutes after teeth brushing
Change in Mucosal impedance 45 minutes after exposure
Time frame: Baseline, 45 minutes after teeth brushing
Change in Mucosal impedance 60 minutes after exposure
Time frame: Baseline, 60 minutes after teeth brushing
Change in IL-33 levels
Time frame: Baseline, approximately 60 minutes after teeth brushing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Mayo Clinic - Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Wright, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal String Test (EST), Colgate and High Resolution Esophageal Manometry (HREM) in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mucosal impedance 15 minutes after exposure (time frame: Baseline, 15 minutes after teeth brushing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.