IBD (Inflammatory Bowel Disease)SPECTROSNCT07781215
E-nose in Evaluating Colitis Activity
An observational study of IBD (Inflammatory Bowel Disease), run by Tampere University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Differential Mobile Spectrometry analysis of the stool
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2026to 31 Dec 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Scheduled for colonoscopy by pediatric gastroenterologist
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stool Profile in Evaluating Colitis Treatment Response, Outcome and Severity
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:
Read more
- 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)
- Being tested
- Differential Mobile Spectrometry analysis of the stool
- Keywords
- Ulcerative Colitis, Crohn's Disease, Rapid test for IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential Mobile Spectrometry analysis of the stoolOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Children without IBD diagnosis (controls) | Children who underwent colonoscopy but did not receive IBD diagnosis Receives: 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) Receives: Other: Differential Mobile Spectrometry analysis of the stool | |
| Children with known IBD (Crohn's disease or colitis) who underwent colonoscopy | Not described Receives: Other: Differential Mobile Spectrometry analysis of the stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images of Fecal molecular profile (FMP) in 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.
Measured: DMS analysis will be performed at each outpatient visit every 3 months during the 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start21 Aug 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Olfactomics Oy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781215
- Sponsor's protocol ID
- R25096
- Acronym
- SPECTROS
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38732837Arasaradnam 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.
PubMed 23478806Covington 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.
PubMed 26205889Ieritano 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.
PubMed 36000315Virtanen 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.
PubMed 36691987Haapala 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.
PubMed 35621655Sioris 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.
PubMed 39456784
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Profile in Evaluating Colitis Treatment Response, Outcome and Severity
- ClinicalTrials.gov ID
- NCT07781215
- Acronym / sponsor ID
- SPECTROS / R25096
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Ulcerative Colitis, Crohn's Disease, Rapid test for IBD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Olfactomics Oy
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children without IBD diagnosis (controls) | – | Other: Differential Mobile Spectrometry analysis of the stoolChildren who underwent colonoscopy but did not receive IBD diagnosis |
| Children without IBD who received new IBD diagnosis | – | Other: Differential Mobile Spectrometry analysis of the stoolChildren without IBD who underwent colonoscopy and the outcome showed IBD (Crohn's disease or colitis) |
| Children with known IBD (Crohn's disease or colitis) who underwent colonoscopy | – | Other: Differential Mobile Spectrometry analysis of the stool |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Scheduled for colonoscopy by pediatric gastroenterologist
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Differential Mobile Spectrometry analysis of the stoolThe 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). | Other | 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 |
Primary outcome
Images of Fecal molecular profile (FMP) in children with and without IBD
Time frame: DMS analysis will be performed at each outpatient visit every 3 months during the 5 year follow-up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 38732837Vermeer 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.
- Background: PubMed 23478806Arasaradnam 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.
- Background: PubMed 26205889Covington 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.
- Background: PubMed 36000315Ieritano 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.
- Background: PubMed 36691987Virtanen 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.
- Background: PubMed 35621655Haapala 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.
- Background: PubMed 39456784Sioris 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease), run by Tampere University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Räisänen, PhD (+358444735309, laura.raisanen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Images of Fecal molecular profile (FMP) in children with and without IBD (time frame: DMS analysis will be performed at each outpatient visit every 3 months during the 5 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781215, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.