Investigating Serotonin Signalling in IBD Patients
Observational · No treatment assigned · 1 site · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 19 to 85
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Patient groups: Disease diagnosis (CD or UC),duration of disease, previous/type of treatments, duration of treatment and disease prognosis.
- Healthy controls: No diagnosis of CD or UC and no diagnosis of IBS.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- The study has 3 groups.
- Start date: 2012-07.
- Main results expected around 2027-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Groups in this study
- Healthy controls
- CD patient groups
- UC patient group
Main thing being measured
- TPH1 (At the time of sample collection)
In the researchers’ words
Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients. Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT production, messenger RNA (mRNA) have been found in CD patients…
Words you might see
- Remission: a period when the disease is quiet or under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | McMaster University |
| Enrollment | 60 (estimated) |
| Start date | 2012-07 |
| Primary completion (est.) | 2027-11 |
| First posted | 2012-07-26 |
| Last updated | 2026-10-09 |
| Official title | Investigating Serotonin Signalling in IBD Patients |
| ClinicalTrials.gov ID | NCT01650311 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Patient groups: Disease diagnosis (CD or UC),duration of disease, previous/type of treatments, duration of treatment and disease prognosis. * Healthy controls: No diagnosis of CD or UC and no diagnosis of IBS. Exclusion Criteria: * Patient groups: Drugs that directly affect components of 5-HT signaling, any other disease or condition that may interfere with study assessments as judged by the investigator. * Healthy controls:Chronic use of any anti-inflammatory drugs, drugs that directly affect components of 5-HT signalling and any other disease or condition that may interfere with study assessments as judged by the investigator.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University Medical Center | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.