buy instagram likes
 

7808: Use of Unsedated Transnasal Esophagoscopy to Monitor Dietary Management of Eosinophilic Esophagitis in Children

Status: RECRUITING

This study will use unsedated (not put to sleep) transnasal endoscopy (TNE) to learn more about how long it takes esophageal eosinophils to come back after either a new food is started or swallowed topical steroid therapy is removed in children with Eosinophilic Esophagitis (EoE). Children in this study will have eliminated one to four foods as treatment for their EoE and will not be taking steroid therapy OR will be taking swallowed topical steroids with any number of foods eliminated.

For Diseases

  • Eosinophilic Esophagitis

Background

Eosinophilic Esophagitis (EoE) is a common (1/10,000 individuals) inflammatory disease of the esophagus (the tube- leading from the mouth to the stomach) that is typically caused by exposure to certain substances in food. In this study, participants will be starting a single food introduction or stopping their swallowed topical steroid therapy so that we can learn more about how long it takes EoE to come back after stopping their swallowed topical steroid therapy or introducing a potential food that would cause EoE. We also want to learn more about Unsedated Transnasal Esophagoscopy (TNE). TNE is a way to do an endoscopy to look at the health of the esophagus, without needing to give patients medication that makes them sleepy. TNE also uses a tube through the nose rather than through the mouth, as is done in a traditional sedated oral endoscopy. 

The research questions are:

  1. To find out if food introductions in children with EoE can occur quicker than every 6-8 weeks and to see how long it takes eosinophils to return to the esophagus after introducing a new food or stopping swallowed topical steroid therapy in a child with EoE.
  2. To evaluate unsedated TNE effectiveness and utility as compared to standard sedated endoscopy.
  3. To evaluate families' satisfaction and factors that impacted choice to use unsedated TNE as compared to standard sedated endoscopy.

This study is a prospective study that will include 30 children between the ages of 5-22 on dietary elimination therapy (four or less foods) for EoE and not on swallowed or oral steroids OR is on swallowed topical steroid therapy with any number of foods eliminated from the diet. The child with EoE needs to be in clinical remission, meaning that he or she should have less than 15 eosinophils on his/her previous esophageal biopsy.

When the participant’s regular physician determines it is time to reintroduce a food to see if it was an EoE trigger food or remove the swallowed topical steroid therapy, and the family would like to participate, each child and their family will be asked to answer questions regarding their diet, age, and symptoms.

 After introducing the new food or stopping swallowed topical steroid treatment, the child will undergo a TNE at 2 and 4 weeks to evaluate the health of his/her esophagus. 6 weeks after starting the new food or stopping swallowed topical steroid therapy (as a child usually does), the child will choose to undergo either a standard sedated endoscopy or one final TNE. After completing the study the child and his/her family will be interviewed about their experience.

For each visit more specifically, you will be asked to:

  1. Fill out questionnaires/surveys regarding your emotions.
  2. Fill out surveys regarding your experience with nasal endoscopy (TNE).
  3. Fill out questionnaires about your diet.
  4. Have unsedated transnasal esophagoscopy (TNE) 2 times. The TNE is a different way to check your esophagus and stomach. An endoscopy usually involves receiving anesthesia (you are put to sleep) and a doctor placing a tube through your mouth down your throat to your stomach. With the TNE you will not need to get anesthesia. The doctor will use a medicine to numb your nose and throat. The doctor will place the tube through your nose to your stomach. The TNE will be 2 weeks and 4 weeks after your regular doctor says to start eating a new food. These procedures are paid for by the study.
  5. Watch a video that shows how the TNE is done.
  6. Have a TNE or the regular procedure (called a sedated (you go to sleep) esophagoscopy) 6 weeks after you start the new food or stop taking swallowed topical steroids. You will need to choose one and have this procedure done. This is the usual test you would have done to check how your EoE is doing. This final scope is the standard scope after food introduction or stopping swallowed topical steroids and will not be paid for by the study.
  7. Have biopsies during the esophagoscopy.
  8. Complete an interview about your decisions to participate in this study and to have the TNE.

Who Can Join

To be eligible to participate, you must:

  • Participant able to understand and provide informed consent/ assent
  • Age between 5-22 years old
  • Historical diagnosis of Eosinophilic Esophagitis
  • EGD or TNE within last 12 months showing EoE Remission
  • No current symptoms attributable to EoE
  • Currently on a four food or less elimination diet not including foods that were eliminated at the time of EoE diagnosis OR on a swallowed topical steroid therapy with any number of foods removed
  • Participant has a negative pregnancy test (child-bearing aged females only)
  • Female subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
  • Participant’s Gastroenterologist or Allergist has recommended reintroduction of food antigen or removal of swallowed topical steroid therapy and the participant and family have agreed to re-introduce the food or remove the swallowed topical steroid
  • Participant and family are willing to undergo multiple unsedated TNE procedures

You are not eligible to participate if:

  • Current diagnosis of bleeding disorder
  • Unwilling to undergo unsedated TNE
  • Unwilling or unable to come to the hospital at least 3 times over 6 weeks
  • Currently treated with swallowed topical steroids for EoE and they are not being discontinued
  • Treatment with oral steroids within 8 weeks of starting the study
  • More than one change is being made to the EoE treatment regimen (e.g., more than a single food is being reintroduced during the study period; the swallowed topical steroid is being discontinued at the same time a food is being introduced)
  • Clinically significant symptoms attributable to EoE including dysphagia, abdominal pain, or vomiting since the last TNE or EGD showing remission
  • Pregnancy, breastfeeding or plans to become pregnant
  • Unable to complete study procedures including TNE or EGD
  • Allergy to any material or medicine used for procedures
  • Use of an investigational product within 16 weeks of starting study
  • Not fluent in English
  • Presence of any condition in the opinion of the investigator would pose additional risk to participation in the study, may interfere the participant’s ability to comply with study requirements or that may impact the quality and integrity of the data obtained from the study
In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to ask about participation.

Colorado

Children’s Hospital Colorado, Aurora, CO

Study Coordinator: Meredith Levy
Phone: 720-777-5279
Email: meredith.levy@childrenscolorado.org


Learn about all the benefits of joining the RDCRN Contact Registry.

Join Now


Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.