Inflammatory Bowel DiseasesTFI-MICINCT03565263
Functional Gastrointestinal Disorders in Pediatric IBD
An observational study of Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by University Hospital, Caen at 1 site in France.
Trial summary
Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders, Pediatric Disorder
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 8 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In the aim of recruiting a sample that will be the most representative possible of the population of pediatric IBD patients in remission in France, patients will be recruited for the study through different procedures: * either during a routine visit to the pediatric gastroenterology clinic (all French pediatric gastroenterology clinics will be study centers) * or during a routine visit to the adult gastroenterology clinic (the French adult gastroenterologists will be informed of the study and will be able to apply to be a study center) * finally, the patient will be able to find information on the study through the French IBD patient Foundation (association Francois Aupetit) and contact the investigators in order to participate.
Who may be able to join
- IBD (Crohns disease, Ulcerative colitis or IBD-U)
- in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C reactive protein < 10 mg/L, erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
- followed for IBD for at least 1 year
Who cannot join
- presence of an ileostomy or colostomy
- past history of total colectomy
- unable to understand written French or to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors
Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.
Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.
Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.
- Conditions
- Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders, Pediatric Disorder, Anxiety Depression, Quality of Life
- Medical subject headings
- Inflammatory Bowel Diseases, Gastrointestinal Diseases
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 |
|---|---|---|
| FGID-IBD | * Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy * followed for IBD for at least 1 year * with at least one Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria) | |
| No FGID-IBD | * Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy * followed for IBD for at least 1 year * not a single Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Functional Gastrointestinal Disorder
Rome III criteria for FGID (Fr-qPGS questionnaire)
Measured: baseline
Secondary outcomes (6)
Anxiety
SCARED-R questionnaire
Measured: baseline
Depression
CDI questionnaire
Measured: baseline
Quality of life - disease related
IMPACT-III questionnaire
Measured: baseline
Fatigue
peds FACIT-F questionnaire
Measured: baseline
Anxiety (parents)
STAI/Y-A and STAI/Y-B questionnaires
Measured: baseline
Depression (parents)
BDI questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start3 Apr 2018
- Primary completion8 Feb 2019
- Study completion8 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Dupont-Lucas, Principal investigator, Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565263
- Sponsor's protocol ID
- 17-160
- Acronym
- TFI-MICI
- Status last verified
- Nov 2020
- First submitted
- 9 Feb 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors
- ClinicalTrials.gov ID
- NCT03565263
- Acronym / sponsor ID
- TFI-MICI / 17-160
- Conditions
- Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders, Pediatric Disorder, Anxiety Depression, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Nov 2020 (actual)
- First posted
- 21 Jun 2018 (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.
Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.
Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.
Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGID-IBD | – | –* Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy * followed for IBD for at least 1 year * with at least one Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria) |
| No FGID-IBD | – | –* Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C-reactive-protein < 10 mg/L, Erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy * followed for IBD for at least 1 year * not a single Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria) |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In the aim of recruiting a sample that will be the most representative possible of the population of pediatric IBD patients in remission in France, patients will be recruited for the study through different procedures: * either during a routine visit to the pediatric gastroenterology clinic (all French pediatric gastroenterology clinics will be study centers) * or during a routine visit to the adult gastroenterology clinic (the French adult gastroenterologists will be informed of the study and will be able to apply to be a study center) * finally, the patient will be able to find information on the study through the French IBD patient Foundation (association Francois Aupetit) and contact the investigators in order to participate.
Key inclusion criteria (3 listed)
- IBD (Crohns disease, Ulcerative colitis or IBD-U)
- in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, < or = 3 stools/day, C reactive protein < 10 mg/L, erythrocyte sedimentation rate < 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
- followed for IBD for at least 1 year
Key exclusion criteria (3 listed)
- presence of an ileostomy or colostomy
- past history of total colectomy
- unable to understand written French or to answer the questionnaires
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
Presence of Functional Gastrointestinal Disorder
Time frame: baseline
Rome III criteria for FGID (Fr-qPGS questionnaire)
6 secondary outcomes
Anxiety
Time frame: baseline
Depression
Time frame: baseline
Quality of life - disease related
Time frame: baseline
Fatigue
Time frame: baseline
Anxiety (parents)
Time frame: baseline
Depression (parents)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Claire Dupont-Lucas principal investigator
Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques
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 Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by University Hospital, Caen at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of Functional Gastrointestinal Disorder (time frame: baseline). 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 17 Nov 2020.