Eosinophilic EsophagitisNCT04941742
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
An observational study of Eosinophilic Esophagitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 22 Dec 2021
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients will be recruited from the outpatient clinic of the Pediatric Gastroenterology Division of The University of Texas Health and Science Center at Houston.
Who may be able to join
- Pediatric patient, ages 5-18 years old, who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE
- Signed informed consent by a parent or legal guardian
- Signed assent form by the child/adolescent subjects 7-18 years of age
Who cannot join
- Past medical history of active asthma, active allergic rhinitis, inflammatory bowel disease (IBD), parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels
- Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well
- Asthma questionnaire and/or Spirometry test consistent with asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
The purpose of this study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE.
The hypothesis is that a combination of elevated fractional exhaled nitric oxide, increased peripheral eosinophils, and elevated plasma citrulline and ß-alanine is associated with active EoE.
- Conditions
- Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active eosinophilic esophagitis | Not described | |
| Eosinophilic esophagitis in remission | Not described | |
| No eosinophilic esophagitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractionated exhaled nitric oxide (FeNO) level
The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
Measured: baseline (day of first endoscopy)
Fractionated exhaled nitric oxide (FeNO) level
The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
Measured: at about 4-12 weeks (day of second endoscopy)
Secondary outcomes (8)
Esophageal eosinophil counts as assessed by biopsy
Measured: baseline (day of first endoscopy)
Esophageal eosinophil counts as assessed by biopsy
Measured: at about 4-12 weeks (day of second endoscopy)
Blood eosinophil counts as assessed by complete blood count (CBC)
Measured: baseline (day of first endoscopy)
Blood eosinophil counts as assessed by complete blood count (CBC)
Measured: at about 4-12 weeks (day of second endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography
Measured: baseline (day of first endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography
Measured: at about 4-12 weeks (day of second endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography
Measured: baseline (day of first endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography
Measured: at about 4-12 weeks (day of second endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start22 Sep 2020
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tu Thanh Mai, The University of Texas Health Science Center, Houston
- Investigators
- Tu T Mai, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941742
- Sponsor's protocol ID
- HSC-MS-18-1019 (validation)
- Status last verified
- May 2024
- First submitted
- 21 Jun 2021
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Josyabhatla R, Abrenica C, Mai T, Hashmi SS, Liu Y, Mosquera R, Van Arsdall M, Navarro F, Tchakarov A, Tatevian N, Wu G, Rhoads JM. Plasma Biomarkers and Fractional Exhaled Nitric Oxide in the Diagnosis of Eosinophilic Esophagitis. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):59-65. doi: 10.1097/MPG.0000000000003634. Epub 2022 Oct 11.
PubMed 36574003
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04941742
- Acronym / sponsor ID
- HSC-MS-18-1019 (validation)
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 28 Jun 2021 (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 study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE.
The hypothesis is that a combination of elevated fractional exhaled nitric oxide, increased peripheral eosinophils, and elevated plasma citrulline and ß-alanine is associated with active EoE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active eosinophilic esophagitis | – | – |
| Eosinophilic esophagitis in remission | – | – |
| No eosinophilic esophagitis | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients will be recruited from the outpatient clinic of the Pediatric Gastroenterology Division of The University of Texas Health and Science Center at Houston.
Key inclusion criteria (3 listed)
- Pediatric patient, ages 5-18 years old, who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE
- Signed informed consent by a parent or legal guardian
- Signed assent form by the child/adolescent subjects 7-18 years of age
Key exclusion criteria (3 listed)
- Past medical history of active asthma, active allergic rhinitis, inflammatory bowel disease (IBD), parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels
- Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well
- Asthma questionnaire and/or Spirometry test consistent with asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractionated exhaled nitric oxide (FeNO) level
Time frame: baseline (day of first endoscopy)
The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
Fractionated exhaled nitric oxide (FeNO) level
Time frame: at about 4-12 weeks (day of second endoscopy)
The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
8 secondary outcomes
Esophageal eosinophil counts as assessed by biopsy
Time frame: baseline (day of first endoscopy)
Esophageal eosinophil counts as assessed by biopsy
Time frame: at about 4-12 weeks (day of second endoscopy)
Blood eosinophil counts as assessed by complete blood count (CBC)
Time frame: baseline (day of first endoscopy)
Blood eosinophil counts as assessed by complete blood count (CBC)
Time frame: at about 4-12 weeks (day of second endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography
Time frame: baseline (day of first endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography
Time frame: at about 4-12 weeks (day of second endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography
Time frame: baseline (day of first endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography
Time frame: at about 4-12 weeks (day of second endoscopy)
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 10 May 2024.
- Results publication: PubMed 36574003Josyabhatla R, Abrenica C, Mai T, Hashmi SS, Liu Y, Mosquera R, Van Arsdall M, Navarro F, Tchakarov A, Tatevian N, Wu G, Rhoads JM. Plasma Biomarkers and Fractional Exhaled Nitric Oxide in the Diagnosis of Eosinophilic Esophagitis. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):59-65. doi: 10.1097/MPG.0000000000003634. Epub 2022 Oct 11.
- 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.
Tu T Mai, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 3 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 10 May 2024. 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?
Fractionated exhaled nitric oxide (FeNO) level (time frame: baseline (day of first endoscopy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941742, which also lists 1 linked publication.
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 10 May 2024.