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E-nose in Evaluating Colitis Activity

NCT07781215 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-08-24

No results posted yet for this study

Summary

The goal of this observational study is to learn whether a rapid stool-based imaging test can help monitor inflammatory bowel disease (IBD) in children. The study will use a technology called differential mobility spectrometry (DMS) to analyze the molecular profile of stool samples. Researchers hope this method will provide a quick, non-invasive way to measure bowel inflammation and predict disease worsening.

The main questions it aims to answer are:

* Do children with IBD have different stool molecular profiles than children without IBD?
* Can stool molecular profiles reflect how much inflammation is present in the bowel?
* Can stool molecular profiles help predict disease relapse or the need for stronger treatment?
* Can changes in stool molecular profiles show whether treatment is working?

Current methods used to monitor IBD have limitations. Blood tests, symptom scores, stool calprotectin tests, ultrasound, and endoscopy can help measure inflammation, but some tests are invasive, may not give immediate results, or may not accurately predict future disease activity. Researchers want to determine whether stool molecular profiling can provide additional information to support clinical care.

The study will include children younger than 18 years who are undergoing colonoscopy at Tampere University Hospital. Participants with IBD will be followed regularly for up to 5 years or until they transfer to adult care. Researchers will track disease activity, relapses, and treatment changes over time. Children without IBD will participate only at the baseline visit.

Participants with IBD will provide stool samples for stool molecular profiling and faecal calprotectin testing, and undergo routine assessments of disease activity, including symptom scores, blood tests, intestinal ultrasound, and elastography. Information from clinically indicated colonoscopies and tissue samples will be reviewed and compared to stool profiles. Attend follow-up visits will be performed approximately every 3 months for monitoring treatment response, relapses, and the need for treatment escalation. Researchers will compare stool molecular profiles between children with and without IBD. They will also compare patterns seen during remission and active disease and evaluate whether certain profiles are linked to treatment-resistant disease.

This study is expected to involve minimal risk because it mainly uses stool samples and clinical information collected during routine care. If successful, the findings could help develop a rapid and non-invasive tool that provides real-time information about bowel inflammation, reduces the need for invasive testing, and helps identify children at risk of relapse before symptoms worsen. This could support earlier and more personalized treatment decisions for children with IBD.

Conditions

  • IBD (Inflammatory Bowel Disease)

Interventions

OTHER

Differential Mobile Spectrometry analysis of the stool

The stool that is checked for faecal calprotectin will also be analysed using the DMS, which generates different ion spectra that will be referred as faecal molecular profile (FMP).

Sponsors & Collaborators

  • Olfactomics Oy

    collaborator UNKNOWN

  • Tampere University Hospital

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-21
Primary Completion
2036-12-31
Completion
2036-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781215 on ClinicalTrials.gov