E-nose in Evaluating Colitis Activity

NCT07781215 | Not Yet Recruiting

• 1 other identifier: R25096
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

ulcerative colitis, crohn's disease, clinical follow-up

Outcome Measures

Primary Outcomes (1)

• Fecal molecular profile (FMP) of children with and without IBD

  Based on the DMS analysis of the stool, FMP and fecal calprotectin of children with IBD (both newly diagnosed and already treated) will be compared to those without IBD.

  DMS analysis will be performed at each outpatient visit every 3 months during the 5 year follow-up

Study Arms (3)

Children without IBD diagnosis (controls)

Children who underwent colonoscopy but did not receive IBD diagnosis

Other: Differential Mobile Spectrometry analysis of the stool

Children without IBD who received new IBD diagnosis

Children without IBD who underwent colonoscopy and the outcome showed IBD (Crohn's disease or colitis)

Other: Differential Mobile Spectrometry analysis of the stool

Children with known IBD (Crohn's disease or colitis) who underwent colonoscopy

Other: Differential Mobile Spectrometry analysis of the stool

Interventions

Differential Mobile Spectrometry analysis of the stool OTHER

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).

Children with known IBD (Crohn's disease or colitis) who underwent colonoscopy; Children without IBD diagnosis (controls); Children without IBD who received new IBD diagnosis

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who are treated at the pediatric gastroenterology unit in Tampere University Hospital, have consented for the study, and are scheduled for colonoscopy

You may qualify if:

• Scheduled for colonoscopy by pediatric gastroenterologist

You may not qualify if:

• None

Sponsors & Collaborators

• Tampere University Hospital: lead
• Olfactomics Oy: collaborator

Related Publications (7)

• Vermeer E, Jagt JZ, Stewart TK, Covington JA, Struys EA, de Jonge R, de Boer NKH, de Meij TGJ. Faecal Volatile Organic Compound Analysis in De Novo Paediatric Inflammatory Bowel Disease by Gas Chromatography-Ion Mobility Spectrometry: A Case-Control Study. Sensors (Basel). 2024 Apr 25;24(9):2727. doi: 10.3390/s24092727.

  PMID: 38732837 BACKGROUND

• Arasaradnam RP, Ouaret N, Thomas MG, Quraishi N, Heatherington E, Nwokolo CU, Bardhan KD, Covington JA. A novel tool for noninvasive diagnosis and tracking of patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013 Apr;19(5):999-1003. doi: 10.1097/MIB.0b013e3182802b26.

  PMID: 23478806 BACKGROUND

• Covington JA, van der Schee MP, Edge AS, Boyle B, Savage RS, Arasaradnam RP. The application of FAIMS gas analysis in medical diagnostics. Analyst. 2015 Oct 21;140(20):6775-81. doi: 10.1039/c5an00868a.

  PMID: 26205889 BACKGROUND

• Ieritano C, Hopkins WS. The hitchhiker's guide to dynamic ion-solvent clustering: applications in differential ion mobility spectrometry. Phys Chem Chem Phys. 2022 Sep 14;24(35):20594-20615. doi: 10.1039/d2cp02540j.

  PMID: 36000315 BACKGROUND

• Virtanen J, Roine A, Kontunen A, Karjalainen M, Numminen J, Oksala N, Rautiainen M, Kivekas I. The Detection of Bacteria in the Maxillary Sinus Secretion of Patients With Acute Rhinosinusitis Using an Electronic Nose: A Pilot Study. Ann Otol Rhinol Laryngol. 2023 Nov;132(11):1330-1335. doi: 10.1177/00034894231151301. Epub 2023 Jan 24.

  PMID: 36691987 BACKGROUND

• Haapala I, Kondratev A, Roine A, Makela M, Kontunen A, Karjalainen M, Laakso A, Koroknay-Pal P, Nordfors K, Haapasalo H, Oksala N, Vehkaoja A, Haapasalo J. Method for the Intraoperative Detection of IDH Mutation in Gliomas with Differential Mobility Spectrometry. Curr Oncol. 2022 May 4;29(5):3252-3258. doi: 10.3390/curroncol29050265.

  PMID: 35621655 BACKGROUND

• Sioris P, Makela M, Kontunen A, Karjalainen M, Vehkaoja A, Oksala N, Roine A. Identification of Phospholipids Relevant to Cancer Tissue Using Differential Ion Mobility Spectrometry. Int J Mol Sci. 2024 Oct 13;25(20):11002. doi: 10.3390/ijms252011002.

  PMID: 39456784 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Laura Räisänen, PhD

CONTACT

+358444735309; laura.raisanen@tuni.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: August 24, 2026

Record last verified: 2026-08