Eosinophilic EsophagitisEoENCT02314455
Esophageal Absorption in EoE
A study testing D-xylose in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- D-xylose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study
- endoscopy with esophageal and duodenal biopsies within two weeks of performance of this study
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study, and are now in histologic remission( <15phf) by the use of steroids or the six food elimination diet.
- Volunteers will be selected for not having any history of esophageal symptoms
Who cannot join
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
- Patients taking Nsaids within 48 hours of the d-xylose testing
- artificial sweeteners within 48 hours of the d-xylose testing
- History of IBD
- Currently smoking or history of smoking
- History of Celiac disease
Show all 9Show fewer
- Bacterial overgrowth,
- motility disorders
- other diffuse small bowel diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Esophageal Absorption in Eosinophilic Esophagitis
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- D-xylose
- Keywords
- Eosinophilic Esophagitis, EoE, dysphagia
- Medical subject headings
- Eosinophilic Esophagitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-xyloseOther
Also called Eosinophilic esophagitis, Absorption study
There will be four patient groups analyzed. Ten patients each, 10 with active eosinophilic esophagitis defined by consensus guidelines, 20 patients in histologic remission (10 by steroids and 10 by diet) and 10 control volunteers will be studied. Patients who have consented to the trial will be scheduled at the Clinical Research Unit (CRU) Patients will report to Charlton 7 the CRU, having their height, weight, blood pressure and temperature recorded. Subjects can choose to either have a saline lock IV placed or have their bloods drawn 3 separate times. They will receive 25 grams of D-xylose orally. The D-xylose will be mixed in 10 cc of water with 2 teaspoons of honey. D-xylose serum levels will be drawn at 5 and 10 and 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| D-xylose, water, honey | Experimental | * 25 grams of D-xylose
* 10 cc of water
* 2 teaspoons of honey Receives: Other: D-xylose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the d-xylose testing defined by the serum levels
D-xylose serum levels will be drawn at 5 and 10 and 60 minutes. D-xylose levels will be compared between the patients with active EOE and healthy controls using the Wilcoxon rank sum test.
Measured: 1 year
Secondary outcomes (1)
D-xylose testing compared to endoscopy/biopsy findings.
Histologic parameters will include grading of spongiosis as an indicator of dilated intercellular spaces which will be correlated to serum levels of D-xylose.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Early analysis showed negative results. It was decided to halt the study.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David Katzka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314455
- Sponsor's protocol ID
- 13-009092
- Acronym
- EoE
- Status last verified
- Jul 2016
- First submitted
- 10 Nov 2014
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Absorption in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02314455
- Acronym / sponsor ID
- EoE / 13-009092
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, EoE, dysphagia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early analysis showed negative results. It was decided to halt the study.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-xylose, water, honey | Experimental | Other: D-xylose* 25 grams of D-xylose * 10 cc of water * 2 teaspoons of honey |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study
- endoscopy with esophageal and duodenal biopsies within two weeks of performance of this study
- Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study, and are now in histologic remission( <15phf) by the use of steroids or the six food elimination diet.
- Volunteers will be selected for not having any history of esophageal symptoms
Key exclusion criteria (9 listed)
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
- Patients taking Nsaids within 48 hours of the d-xylose testing
- artificial sweeteners within 48 hours of the d-xylose testing
- History of IBD
- Currently smoking or history of smoking
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 |
|---|---|---|
| D-xyloseAlso: Eosinophilic esophagitis, Absorption studyThere will be four patient groups analyzed. Ten patients each, 10 with active eosinophilic esophagitis defined by consensus guidelines, 20 patients in histologic remission (10 by steroids and 10 by diet) and 10 control volunteers will be studied. Patients who have consented to the trial will be scheduled at the Clinical Research Unit (CRU) Patients will report to Charlton 7 the CRU, having their height, weight, blood pressure and temperature recorded. Subjects can choose to either have a saline lock IV placed or have their bloods drawn 3 separate times. They will receive 25 grams of D-xylose orally. The D-xylose will be mixed in 10 cc of water with 2 teaspoons of honey. D-xylose serum levels will be drawn at 5 and 10 and 60 minutes. | Other | D-xylose, water, honey |
Primary outcome
Reliability of the d-xylose testing defined by the serum levels
Time frame: 1 year
D-xylose serum levels will be drawn at 5 and 10 and 60 minutes. D-xylose levels will be compared between the patients with active EOE and healthy controls using the Wilcoxon rank sum test.
1 secondary outcome
D-xylose testing compared to endoscopy/biopsy findings.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Early analysis showed negative results. It was decided to halt the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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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.
David Katzka, 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 D-xylose 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Jul 2016. 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 was stopped early (reason given: Early analysis showed negative results. It was decided to halt the study.). Results are not available in the source record.
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?
Reliability of the d-xylose testing defined by the serum levels (time frame: 1 year). 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 21 Jul 2016; AzTrials last refreshed its copy on 28 Oct 2026.