Cystic Fibrosis in ChildrenNCT04392544
Intestinal Inflammation in CF Patients
An observational study of Cystic Fibrosis in Children and Cystic Fibrosis Gastrointestinal Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis in Children, Cystic Fibrosis Gastrointestinal Disease, Cystic Fibrosis
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2018to 31 Dec 2025
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult population diagnosed of cystic fibrosis will be included in this study.
Who may be able to join
- Pediatric cohort:
- Diagnosis of CF
- Informed consent obtained
- Age 10-18 years
- Adult cohort:
- Diagnosis of CF
Show all 9Show fewer
- Informed consent obtained
- Age ≥ 18 years
- Patient undergoing a colonoscopy for a clinical indication
Who cannot join
- Pediatric Cohort:
- Patients with the diagnosis of IBD.
- Patients during an episode of acute gastroenteritis or a pulmonary exacerbation.
- Adult cohort:
- Patients with the diagnosis of IBD.
- Any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interrogation of the Prevalence of Intestinal Inflammation in Cystic Fibrosis Patients and the Correlation with Abdominal Symptoms
Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.
Read the detailed description
The aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult CF populations.
Pediatric CF population (Age 10-18 years):
- Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.
- Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.
Adult CF population (Age ≥ 18 years):
- Determine the prevalence of intestinal inflammation in a cohort of adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples
- in adult CF patients who have not undergone lung or liver transplantation.
- in adult CF patients who have undergone lung or liver transplantation.
- Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
- Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric | Pediatric CF population age 10-18 years. | |
| Adult | Adult CF population age ≥ 18 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation.
Measured: Day 1
Assess the correlation between fecal calprotectin levels and abdominal symptoms.
Measured: Day 1
Determine the prevalence of intestinal inflammation in adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples.
Sub groups; with and without lung or liver transplantation.
Measured: Day 1
Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
Measured: Day 1
Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start11 Sep 2018
- Primary completion31 Mar 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Tanja Gonska, The Hospital for Sick Children
- Investigators
- Tanja Gonska, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392544
- Sponsor's protocol ID
- 1000060079
- Status last verified
- Jan 2025
- First submitted
- 13 May 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrogation of the Prevalence of Intestinal Inflammation in Cystic Fibrosis Patients and the Correlation with Abdominal Symptoms
- ClinicalTrials.gov ID
- NCT04392544
- Acronym / sponsor ID
- 1000060079
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Cystic Fibrosis Foundation
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 May 2020 (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.
Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.
Detailed description
The aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult CF populations.
Pediatric CF population (Age 10-18 years):
- Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.
- Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.
Adult CF population (Age ≥ 18 years):
- Determine the prevalence of intestinal inflammation in a cohort of adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples
- in adult CF patients who have not undergone lung or liver transplantation.
- in adult CF patients who have undergone lung or liver transplantation.
- Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
- Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric | – | –Pediatric CF population age 10-18 years. |
| Adult | – | –Adult CF population age ≥ 18 years. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult population diagnosed of cystic fibrosis will be included in this study.
Key inclusion criteria (9 listed)
- Diagnosis of CF
- Informed consent obtained
- Age 10-18 years
- Diagnosis of CF
- Informed consent obtained
Key exclusion criteria (6 listed)
- Patients with the diagnosis of IBD.
- Patients during an episode of acute gastroenteritis or a pulmonary exacerbation.
- Patients with the diagnosis of IBD.
- Any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation.
Time frame: Day 1
Assess the correlation between fecal calprotectin levels and abdominal symptoms.
Time frame: Day 1
Determine the prevalence of intestinal inflammation in adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples.
Time frame: Day 1
Sub groups; with and without lung or liver transplantation.
Determine the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
Time frame: Day 1
Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms in adult CF patients.
Time frame: Day 1
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 20 Jan 2025.
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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. This study is not recruiting at the moment.
Tanja Gonska, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children and Cystic Fibrosis Gastrointestinal Disease, run by The Hospital for Sick Children at 1 site in Canada.
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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure fecal calprotectin levels in stool samples of CF pediatric population to determine prevalence of intestinal inflammation. (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.