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Can a smartphone app unlock the link between infections and FMF attacks?

NCT ID NCT07212764

Knowledge-focused Sponsor: Istanbul University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will enroll 40 children aged 8-18 with Familial Mediterranean Fever (FMF) to see if infections trigger disease flares. Participants will use a mobile app to log symptoms like fever, cough, or sore throat in real time. The goal is to better understand the infection-flare connection and improve patient care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that mobile apps help doctors understand how infections trigger FMF attacks, leading to better management and fewer unnecessary treatments.
What could go wrong
This is a small, early-stage observational study with only 40 participants. It does not test a new treatment, so it may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will include children and adolescents aged 6-18 years with a diagnosis of Familial Mediterranean Fever (FMF) according to the Tel Hashomer and/or Eurofever criteria. Participants will be under regular follow-up at the pediatric rheumatology clinic and agree to record infection-related symptoms and FMF complaints through a mobile application. Patients with comorbid chronic inflammatory, autoimmune, or immunodeficiency disorders will be excluded. Informed consent from parents/legal guardians and assent from the child will be obtained.

Ages

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Children and adolescents aged 8-18 years FMF diagnosis established by Tel Hashomer and/or Eurofever criteria Regular follow-up at the participating pediatric rheumatology clinic Stable treatment regimen, defined as: Colchicine use for ≥ 4 weeks Biologic or other anti-inflammatory agents stable for ≥ 8 weeks (if applicable) Access to a smartphone or tablet (iOS/Android) with internet and ability to use the study mobile application (caregiver assistance allowed) Language proficiency (patient and/or caregiver) sufficient to use the app and respond to prompts Informed consent from a parent/guardian and assent from the child, as appropriate Exclusion Criteria Co-existing chronic inflammatory or autoimmune disorders that may confound flare/infection assessment (e.g., JIA, IBD, Behçet disease) other than FMF Known primary or secondary immunodeficiency or ongoing immunosuppressive chemotherapy outside standard FMF care Chronic active infection (e.g., TB, HBV, HCV, HIV) or acute febrile illness at enrollment precluding baseline assessment Cognitive, visual, or motor limitations preventing app use without caregiver support No reliable access to a compatible device or internet connection Concurrent participation in another clinical study likely to affect outcomes or reporting Anticipated non-adherence (e.g., inability to complete app entries) as judged by the investigator Refusal or withdrawal of consent/assent

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Conditions

The condition(s) this trial relates to.

familial Mediterranean fever Infections infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Familial mediterranean fever (FMF) Infection Mobile application

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istanbul University Faculty of Medicine

    Istanbul, Fatih, 34093, Turkey (Türkiye)

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