ClinicalTrials.gg
RecruitingNCT05730933Updated May 31, 2025

An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.

An interventional study of Intervention in Eosinophilic Esophagitis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Eosinophilic Esophagitis with a site in Netherlands — 3 open to participants now, 5 under way, 1 of them phase 3. Eosinophilic Esophagitis · Netherlands.

Planned enrollment
9th of 10
72 · median 151
Started
2023
with 1 other
No phase
Only one
of the 11
Registered
9th of 11
by date
Lead sponsor
2 of 11
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Among the 11 studies in Eosinophilic Esophagitis with a site in Netherlands, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2023, is the only one with no phase, and was the 9th registered.

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

Browse Eosinophilic Esophagitis studies →

Open to participants now

3 of the 11 studies in Eosinophilic Esophagitis with a site in Netherlands are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Eosinophilic Esophagitis with a site in Netherlands, or all of them as a file.
02

Study summary

In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.

03

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • eosinophilic esophagitis
  • maintenance treatment
  • compliance
  • intervention
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written
  • Male or female patient
  • Age >18 years
  • Previous diagnosis of EoE, confirmed by histopathology, with the presence of >15 eosinophilic granulocytes per high power field (hpf) in esophageal
  • Current maintenance treatment for EoE with a PPI or swallowed topical or about to start with these maintenance medications as decided during regular clinical practice

Exclusion criteria

Exclusion Criteria:

  • Severe and clinically unstable concomitant disease that may interfere with the subject's ability to participate in the study
  • Receive treatment during the study
  • Dilation of esophagus required
  • Insufficient Dutch or English language skills to understand patient information leaflets
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Intervention

    Behavioral: Intervention

  • No intervention
    Control

Interventions

  • BehavioralIntervention

    Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders

06

What researchers measure

Primary outcomes

  1. Treatment adherence at 12 weeks

    Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate

    Time frame: 12 weeks

Secondary outcomes

  1. Treatment adherence at 6 months

    Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate

    Time frame: 6 months

  2. Treatment adherence at 12 months

    Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate

    Time frame: 12 months

  3. Differences in self-reported treatment adherence measured by brief-IPQ

    Differences in self-reported treatment adherence measured by brief-IPQ, a 9 item questionnaire where every item is assessed individually (0 to 10 response scale) except for 1 open-ended response item

    Time frame: 12 weeks, 6 months and 12 months.

  4. Differences in self-reported treatment adherence measured by BMQ

    Differences in self-reported treatment adherence measured by BMQ, questionnaire with 2 subscales. Necessity subscale ranges from 5-20, where lower scores indicate low necessity beliefs. Concern scale ranges from 5-20 where lower scores indicate higher confidence in positive effects of medication.

    Time frame: 12 weeks, 6 months and 12 months.

  5. Differences in self-reported treatment adherence measured by 8-point MMAS

    Differences in self-reported treatment adherence measured by 8-point MMAS. Total scores range between 0 to 8, where a higher score indicates higher treatment adherence

    Time frame: 12 weeks, 6 months and 12 months.

  6. Differences in self-reported treatment adherence measured by MARS questionnaire

    Differences in self-reported treatment adherence measured by MARS questionnaire 5. Scores range between 1-25, where a higher score indicates higher reported treatment adherence

    Time frame: 12 weeks, 6 months and 12 months.

  7. Change in clinical symptoms measured by DSQ questionnaire

    Change in clinical symptoms measured by DSQ questionnaire. Total score range from 0 to 84, where higher scores indicate more symptoms

    Time frame: 12 weeks, 6 months and 12 months

  8. Change in clinical symptoms measured by SDI questionnaire

    Change in clinical symptoms measured by SDI questionnaire. Total scores of the SDI ranges between 0 to 9, where higher scores indicate more symptoms.

    Time frame: 12 weeks, 6 months and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Dec 2025, 32 months after the start.

Of 23 interventional studies with no phase under Eosinophilic Esophagitis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 32 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2023
First posted
Feb 16, 2023
StartActual
Apr 12, 2023
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05730933
Responsible party
Prof.dr. A.J. (Arjan) Bredenoord (Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Feb 16, 2023
Start date
Apr 12, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion