Eosinophilic EsophagitisFREENCT03657771
A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
A study testing DED and FREE in people with Eosinophilic Esophagitis, run by Nemours Children's Clinic at 3 sites in United States.
Trial summary
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE) Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- DED and FREE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2018to 31 Dec 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
- If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
- The participant/parent(s) or legal representative(s)/caregiver(s) are considered reliable and capable of adhering to the protocol call schedule and dietary requirements.
- The participant is >2 years to <18 years of age.
- The participant has isolated esophageal eosinophilia (>15 eos/hpf).
- The family has access to the internet to complete weekly surveys and to a telephone to complete weekly follow up calls.
- The biopsy used to diagnose eosinophilic esophagitis was taken no more than 12 weeks prior to the date of enrollment.
Who cannot join
- The participant has peripheral eosinophilia > 1,500 µL
- The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease).
- The participant has a history of upper GI tract surgery (e.g. fundoplication)
- Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care)
- The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
- The participant has taken prednisone in the last 12 weeks, or has taken fluticasone or budesonide in the last 8 weeks.
Show all 11Show fewer
- The participant has other significant medical conditions that, in the opinion of the provider, would impact the participant's ability to participate in the study.
- The participant has a psychiatric condition that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
- The participant does not speak or read English fluently.
- The participant is currently taking a PPI (If discontinued, no washout required.)
- The participant is currently on or previously failed a dairy free diet for EoE.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nemours Children's Hospital
Orlando, Florida, 32827
Seattle Children's Hospital
Seattle, Washington, 98105
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, 19083
About this study
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)
Read the detailed description
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus. Primary symptoms manifest while eating and include dysphagia, chest pain, and food impaction. EoE was first described in the 1990s, but is increasingly recognized worldwide. It affects both adults and children.
Given that EoE is thought to be an allergen driven disease, elimination diets are considered logical and safe first-line treatment options. Elimination diets focus on the removal of the food groups most likely to evoke the inflammatory response (e.g. dairy, wheat, soy, egg, etc.). This is the first study to examine the effects of an additive free diet on eosinophilic esophagitis.
Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf) of DED and FREE in children with eosinophilic esophagitis.
Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic Reference scores: EREFs) of DED and FREE in children with eosinophilic esophagitis
Tertiary Objectives: To compare symptomatic (Pediatric Eosinophilic Esophagitis Symptom Severity Module v2.0: PEESS) and quality of life (Peds-QL EoE Module 1) outcomes of DED and FREE in children with eosinophilic esophagitis
The investigators plan to enroll 72 patients over 4 sites each enrolling 18 patients per site in a 16-month period (approximately 1 patient per month per site) having 9 patients per site in each group (DED and FREE).
The investigators will enroll patients > 5- <17 years of age with isolated esophageal eosinophilia (>15 eos/hpf). Patients with food impaction, peripheral eosinophilia > 1,500 µL , concomitant GI inflammatory conditions, history of upper GI tract surgery (e.g. fundoplication), acid reflux by pH probe, anaphylactic food allergies, severe developmental delay, taking recently prescribed inhaled corticosteroids or oral corticosteroids, have other medical conditions likely interfere with the study, has a significant psychiatric condition, has taken a PPI in the last 4 weeks, has taken swallowed steroids in the last 12 weeks, or are not fluent in spoken and written English will be excluded.
Participants will be enrolled at: Nemours Children's Hospital, Orlando, FL; Alfred I Dupont Hospital, Wilmington, DE; Seattle Children's Hospital, Seattle, WA
Once eligibility criteria are met, participants will be randomized to DED or FREE study groups. Participants will receive dietary education. Lead dietitians from each site will be identified and the approaches to dietary education will be standardized. Dietary education will be completed at the baseline visit and during follow up phone calls throughout the study.Each participant will complete all study visits in 12 weeks.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- DED, FREE
- Keywords
- Esophagitis, Diet
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEDOther
DED: Diet eliminating dairy
FREEOther
FREE: Diet eliminating dairy and food additives
| Study group | Role | What they receive |
|---|---|---|
| DED | Active comparator | Diet eliminating dairy Receives: Other: DED |
| FREE | Active comparator | Diet eliminating dairy and food additives Receives: Other: FREE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophils Per High Power Field (eos/hpf)
Histologic change differences of maximum eosinophils per high power field
Measured: 12 weeks
Secondary outcomes (1)
Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
An endoscopic outcome measure to follow response to treatment. Scores range from 0 to 15 with higher scores indicating more endoscopic evidence of eosinophilic esophagitis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start12 Nov 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective, parallel
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Mougey, Nemours Children's Clinic
- Investigators
- Edward B. Mougey, PhD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657771
- Sponsor's protocol ID
- 1173700
- Acronym
- FREE
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2018
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franciosi JP, Hommel KA, Bendo CB, King EC, Collins MH, Eby MD, Marsolo K, Abonia JP, von Tiehl KF, Putnam PE, Greenler AJ, Greenberg AB, Bryson RA, Davis CM, Olive AP, Gupta SK, Erwin EA, Klinnert MD, Spergel JM, Denham JM, Furuta GT, Rothenberg ME, Varni JW. PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):57-66. doi: 10.1097/MPG.0b013e31828f1fd2.
PubMed 23478422Martino JV, Van Limbergen J, Cahill LE. The Role of Carrageenan and Carboxymethylcellulose in the Development of Intestinal Inflammation. Front Pediatr. 2017 May 1;5:96. doi: 10.3389/fped.2017.00096. eCollection 2017.
PubMed 28507982Dellon ES, Jensen ET, Martin CF, Shaheen NJ, Kappelman MD. Prevalence of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2014 Apr;12(4):589-96.e1. doi: 10.1016/j.cgh.2013.09.008. Epub 2013 Sep 11.
PubMed 24035773Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.
PubMed 23567357Imam T, Gupta SK. Topical glucocorticoid vs. diet therapy in eosinophilic esophagitis: the need for better treatment options. Expert Rev Clin Immunol. 2016 Aug;12(8):797-9. doi: 10.1080/1744666X.2016.1191947. Epub 2016 Jun 13. No abstract available.
PubMed 27206496Kagalwalla AF, Wechsler JB, Amsden K, Schwartz S, Makhija M, Olive A, Davis CM, Manuel-Rubio M, Marcus S, Shaykin R, Sulkowski M, Johnson K, Ross JN, Riffle ME, Groetch M, Melin-Aldana H, Schady D, Palac H, Kim KA, Wershil BK, Collins MH, Chehade M. Efficacy of a 4-Food Elimination Diet for Children With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1698-1707.e7. doi: 10.1016/j.cgh.2017.05.048. Epub 2017 Jun 8.
PubMed 28603055Newberry C, Lynch K. Can We Use Diet to Effectively Treat Esophageal Disease? A Review of the Current Literature. Curr Gastroenterol Rep. 2017 Aug;19(8):38. doi: 10.1007/s11894-017-0578-5.
PubMed 28730507Groetch M, Venter C, Skypala I, Vlieg-Boerstra B, Grimshaw K, Durban R, Cassin A, Henry M, Kliewer K, Kabbash L, Atkins D, Nowak-Wegrzyn A, Holbreich M, Chehade M; Eosinophilic Gastrointestinal Disorders Committee of the American Academy of Allergy, Asthma and Immunology. Dietary Therapy and Nutrition Management of Eosinophilic Esophagitis: A Work Group Report of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):312-324.e29. doi: 10.1016/j.jaip.2016.12.026.
PubMed 28283156Kagalwalla AF, Sentongo TA, Ritz S, Hess T, Nelson SP, Emerick KM, Melin-Aldana H, Li BU. Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1097-102. doi: 10.1016/j.cgh.2006.05.026. Epub 2006 Jul 21.
PubMed 16860614Gonsalves N, Yang GY, Doerfler B, Ritz S, Ditto AM, Hirano I. Elimination diet effectively treats eosinophilic esophagitis in adults; food reintroduction identifies causative factors. Gastroenterology. 2012 Jun;142(7):1451-9.e1; quiz e14-5. doi: 10.1053/j.gastro.2012.03.001. Epub 2012 Mar 3.
PubMed 22391333Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.
PubMed 24048168Collins MH, Martin LJ, Alexander ES, Boyd JT, Sheridan R, He H, Pentiuk S, Putnam PE, Abonia JP, Mukkada VA, Franciosi JP, Rothenberg ME. Newly developed and validated eosinophilic esophagitis histology scoring system and evidence that it outperforms peak eosinophil count for disease diagnosis and monitoring. Dis Esophagus. 2017 Feb 1;30(3):1-8. doi: 10.1111/dote.12470.
PubMed 26857345
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT03657771
- Acronym / sponsor ID
- FREE / 1173700
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Esophagitis, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Sep 2018 (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.
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)
Detailed description
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus. Primary symptoms manifest while eating and include dysphagia, chest pain, and food impaction. EoE was first described in the 1990s, but is increasingly recognized worldwide. It affects both adults and children.
Given that EoE is thought to be an allergen driven disease, elimination diets are considered logical and safe first-line treatment options. Elimination diets focus on the removal of the food groups most likely to evoke the inflammatory response (e.g. dairy, wheat, soy, egg, etc.). This is the first study to examine the effects of an additive free diet on eosinophilic esophagitis.
Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf) of DED and FREE in children with eosinophilic esophagitis.
Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic Reference scores: EREFs) of DED and FREE in children with eosinophilic esophagitis
Tertiary Objectives: To compare symptomatic (Pediatric Eosinophilic Esophagitis Symptom Severity Module v2.0: PEESS) and quality of life (Peds-QL EoE Module 1) outcomes of DED and FREE in children with eosinophilic esophagitis
The investigators plan to enroll 72 patients over 4 sites each enrolling 18 patients per site in a 16-month period (approximately 1 patient per month per site) having 9 patients per site in each group (DED and FREE).
The investigators will enroll patients > 5- <17 years of age with isolated esophageal eosinophilia (>15 eos/hpf). Patients with food impaction, peripheral eosinophilia > 1,500 µL , concomitant GI inflammatory conditions, history of upper GI tract surgery (e.g. fundoplication), acid reflux by pH probe, anaphylactic food allergies, severe developmental delay, taking recently prescribed inhaled corticosteroids or oral corticosteroids, have other medical conditions likely interfere with the study, has a significant psychiatric condition, has taken a PPI in the last 4 weeks, has taken swallowed steroids in the last 12 weeks, or are not fluent in spoken and written English will be excluded.
Participants will be enrolled at: Nemours Children's Hospital, Orlando, FL; Alfred I Dupont Hospital, Wilmington, DE; Seattle Children's Hospital, Seattle, WA
Once eligibility criteria are met, participants will be randomized to DED or FREE study groups. Participants will receive dietary education. Lead dietitians from each site will be identified and the approaches to dietary education will be standardized. Dietary education will be completed at the baseline visit and during follow up phone calls throughout the study.Each participant will complete all study visits in 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, prospective, parallel
| Arm | Type | Receives |
|---|---|---|
| DED | Active comparator | Other: DEDDiet eliminating dairy |
| FREE | Active comparator | Other: FREEDiet eliminating dairy and food additives |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
- If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
- The participant/parent(s) or legal representative(s)/caregiver(s) are considered reliable and capable of adhering to the protocol call schedule and dietary requirements.
- The participant is >2 years to <18 years of age.
- The participant has isolated esophageal eosinophilia (>15 eos/hpf).
Key exclusion criteria (11 listed)
- The participant has peripheral eosinophilia > 1,500 µL
- The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease).
- The participant has a history of upper GI tract surgery (e.g. fundoplication)
- Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care)
- The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in 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 |
|---|---|---|
| DEDDED: Diet eliminating dairy | Other | DED |
| FREEFREE: Diet eliminating dairy and food additives | Other | FREE |
Primary outcome
Eosinophils Per High Power Field (eos/hpf)
Time frame: 12 weeks
Histologic change differences of maximum eosinophils per high power field
1 secondary outcome
Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
Time frame: 12 weeks
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 Feb 2025.
- Background: PubMed 23478422Franciosi JP, Hommel KA, Bendo CB, King EC, Collins MH, Eby MD, Marsolo K, Abonia JP, von Tiehl KF, Putnam PE, Greenler AJ, Greenberg AB, Bryson RA, Davis CM, Olive AP, Gupta SK, Erwin EA, Klinnert MD, Spergel JM, Denham JM, Furuta GT, Rothenberg ME, Varni JW. PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):57-66. doi: 10.1097/MPG.0b013e31828f1fd2.
- Background: PubMed 28507982Martino JV, Van Limbergen J, Cahill LE. The Role of Carrageenan and Carboxymethylcellulose in the Development of Intestinal Inflammation. Front Pediatr. 2017 May 1;5:96. doi: 10.3389/fped.2017.00096. eCollection 2017.
- Background: PubMed 24035773Dellon ES, Jensen ET, Martin CF, Shaheen NJ, Kappelman MD. Prevalence of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2014 Apr;12(4):589-96.e1. doi: 10.1016/j.cgh.2013.09.008. Epub 2013 Sep 11.
- Background: PubMed 23567357Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.
- Background: PubMed 27206496Imam T, Gupta SK. Topical glucocorticoid vs. diet therapy in eosinophilic esophagitis: the need for better treatment options. Expert Rev Clin Immunol. 2016 Aug;12(8):797-9. doi: 10.1080/1744666X.2016.1191947. Epub 2016 Jun 13. No abstract available.
- Background: PubMed 28603055Kagalwalla AF, Wechsler JB, Amsden K, Schwartz S, Makhija M, Olive A, Davis CM, Manuel-Rubio M, Marcus S, Shaykin R, Sulkowski M, Johnson K, Ross JN, Riffle ME, Groetch M, Melin-Aldana H, Schady D, Palac H, Kim KA, Wershil BK, Collins MH, Chehade M. Efficacy of a 4-Food Elimination Diet for Children With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1698-1707.e7. doi: 10.1016/j.cgh.2017.05.048. Epub 2017 Jun 8.
- Background: PubMed 28730507Newberry C, Lynch K. Can We Use Diet to Effectively Treat Esophageal Disease? A Review of the Current Literature. Curr Gastroenterol Rep. 2017 Aug;19(8):38. doi: 10.1007/s11894-017-0578-5.
- Background: PubMed 28283156Groetch M, Venter C, Skypala I, Vlieg-Boerstra B, Grimshaw K, Durban R, Cassin A, Henry M, Kliewer K, Kabbash L, Atkins D, Nowak-Wegrzyn A, Holbreich M, Chehade M; Eosinophilic Gastrointestinal Disorders Committee of the American Academy of Allergy, Asthma and Immunology. Dietary Therapy and Nutrition Management of Eosinophilic Esophagitis: A Work Group Report of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):312-324.e29. doi: 10.1016/j.jaip.2016.12.026.
- Background: PubMed 16860614Kagalwalla AF, Sentongo TA, Ritz S, Hess T, Nelson SP, Emerick KM, Melin-Aldana H, Li BU. Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1097-102. doi: 10.1016/j.cgh.2006.05.026. Epub 2006 Jul 21.
- Background: PubMed 22391333Gonsalves N, Yang GY, Doerfler B, Ritz S, Ditto AM, Hirano I. Elimination diet effectively treats eosinophilic esophagitis in adults; food reintroduction identifies causative factors. Gastroenterology. 2012 Jun;142(7):1451-9.e1; quiz e14-5. doi: 10.1053/j.gastro.2012.03.001. Epub 2012 Mar 3.
- Background: PubMed 24048168Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.
- Background: PubMed 26857345Collins MH, Martin LJ, Alexander ES, Boyd JT, Sheridan R, He H, Pentiuk S, Putnam PE, Abonia JP, Mukkada VA, Franciosi JP, Rothenberg ME. Newly developed and validated eosinophilic esophagitis histology scoring system and evidence that it outperforms peak eosinophil count for disease diagnosis and monitoring. Dis Esophagus. 2017 Feb 1;30(3):1-8. doi: 10.1111/dote.12470.
- 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.
Edward B. Mougey, PhD principal investigator
Nemours Children's Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DED and FREE in people with Eosinophilic Esophagitis, run by Nemours Children's Clinic at 3 sites 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 7 inclusion and 11 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Eosinophils Per High Power Field (eos/hpf) (time frame: 12 weeks). 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 NCT03657771, which also lists 12 linked publications.
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 Feb 2025.