Inflammatory Bowel DiseasesNCT05221281
Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
A study testing Multimodal intervention consisting of four core components in people with Inflammatory Bowel Diseases and Crohn Disease, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning… Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Multimodal intervention consisting of four core components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesCanada
- Study dates
- 25 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- 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 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 16-17.5 years
- Diagnosed with IBD diagnosed using standard criteria
- Ability to speak/read English at a functional (Grade 8) level
- Intention to reside in Canada after transfer to adult care
- Ability to use a smartphone or personal computer for the virtual intervention
Who cannot join
- Do not speak English fluently
- Intention to leave Canada after graduation from high school
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada.
Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program.
Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Adolescent Development, Transition, Mental Health Wellness 1
- Being tested
- Multimodal intervention consisting of four core components, Standard of care
- Keywords
- Transition from Pediatric to Adult Care, Health Services Research, Adolescent Medicine
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention consisting of four core componentsBehavioural
Core Component 1: Individualized Assessment: Each participant will undergo individualized assessment of their biopsychosocial risk profile (PIBD INTERMED), self-efficacy (IBD-SES-A), function (IBD-DI), transition readiness (TRAQ) and IBD knowledge (IBD-KID2), and depression, anxiety and activation.
Core Component 2: Transition Navigator: Participants will be assigned a transition navigators, who will have knowledge of IBD, an understanding of the care pathway involved in transitioning IBD patients, and the skills and ability to provide psychosocial support.
Core Component 3: Participant Skills-building: Skills-building materials delivered virtually. Navigators will also be trained as motivational coaches and will lead separate personalized virtual sessions targeting individual skills that have been identified as deficient during the assessment phase.
Core Component 4: eLearning Curriculum: Organized online eLearning modules with reinforcement of knowledge by the navigators.
Standard of careBehavioural
Also called Control
The control group will be provided a standardized version of routine care for transition. In addition to recruiting centers' standard of care, all participating centers will implement the following transition interventions:
- A written letter explaining the goals of transition to the patient and family.
- Completion of age-appropriate checklists to ensure adolescents are meeting milestones of transition (developed by the TRACC Network).51
- Annual online live educational webinars on transition and adolescent issues (hosted by the CIDsCaNN Education Committee).
- Completion of the Pediatric INTERMED,52 with appropriate biopsychosocial intervention.
- Completion of a transfer-of-care summary letter sent to the receiving adult gastroenterologist using a standardized letter template.53
The Control Group may also receive any interventions currently in place in their participating care center, but will not receive the formal 4-component intervention described below.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Multimodal intervention consisting of four core components. | Experimental | Core Component 1: Individualized Assessment
Core Component 2: Transition Facilitation with a Navigator
Core Component 3: Participant Skills-building
Core Component 4: Structured Educational eLearning Curriculum Receives: Behavioral: Multimodal intervention consisting of four core components |
| Control: Standard of care | Other | Routine Care Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBD Disability Index (IBD-DI)
Ordinal variable that measures participant functioning as the primary outcome. IBD-DI was selected as a validated measure of overall disability, functioning, and health. The primary outcome will be measured 3 years after enrollment.
Measured: 3 years
Secondary outcomes (24)
Transition Readiness Assessment Questionnaire (TRAQ)
Transition Readiness
Measured: 3 years
Transition Readiness Assessment Questionnaire (TRAQ)
Transition Readiness
Measured: Up to 24 months (at time of transfer to adult care)
Transition Success Scores (TSS)
Transition Readiness
Measured: 3 years
Transition Success Scores (TSS)
Transition Readiness
Measured: Up to 24 months (at time of transfer to adult care)
Pediatric IBD INTERMED
Biopsychosocial Risk Profile
Measured: 3 years
Pediatric IBD INTERMED
Biopsychosocial Risk Profile
Measured: Up to 24 months (at time of transfer to adult care)
IBD-KID2
Disease-related knowledge
Measured: 3 years
IBD-KID2
Disease-related knowledge
Measured: Up to 24 months (at time of transfer to adult care)
IBDQ-32
Quality of life
Measured: 3 years
IBDQ-32
Quality of life
Measured: Up to 24 months (at time of transfer to adult care)
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Self-Efficacy
Measured: 3 years
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Self-Efficacy
Measured: Up to 24 months (at time of transfer to adult care)
Physician Global Assessment (PGA)
Physician assessment of disease activity
Measured: 3 years
Physician Global Assessment (PGA)
Physician assessment of disease activity
Measured: Up to 24 months (at time of transfer to adult care)
Fecal calprotectin
Measure of gut inflammation
Measured: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Disease activity in Crohn's disease patients
Measured: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Disease activity in Crohn's disease patients
Measured: Up to 24 months (at time of transfer to adult care)
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Disease activity in ulcerative colitis patients
Measured: 3 years
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Disease activity in ulcerative colitis patients
Measured: Up to 24 months (at time of transfer to adult care)
Emergency department visit after 18th birthday (yes/no)
Health services utilization
Measured: 3 years
Number of emergency department visits after 18th birthday
Health services utilization
Measured: 3 years
Hospitalization after 18th birthday (yes/no)
Health services utilization
Measured: 3 years
Number of outpatient visits to a gastroenterologist after 18th birthday
Health services utilization
Measured: 3 years
IBD Disability Index (IBD-DI)
Ordinal variable that measures participant functioning as the primary outcome. IBD-DI was selected as a validated measure of overall disability, functioning, and health.
Measured: Up to 24 months (at time of transfer to adult care)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start25 Feb 2022
- Primary completion1 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Canada, The Leona M. and Harry B. Helmsley Charitable Trust, The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation, The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders
- Responsible party
- Principal investigator, Eric Benchimol, The Hospital for Sick Children
- Investigators
- Eric I Benchimol, MD, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221281
- Sponsor's protocol ID
- 1000078476
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: * Location of the repository - OSF.io or journal (planned) * Administrators for the repository Since we are not sure which journals we will submit to at this time, we cannot comment on the location/administrators for the repository. * De-identified study data plans - At a minimum, research journals are asking that authors share a 'minimal data set' for submission. This is normally defined as the minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods. This is what will be shared with journals upon submission. * Privacy protections for stored study data - Only de-identified study data will be shared with the open access repository. Submission to research journals has been outlined on the participant consent form.
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077Bollegala N, Barwick M, Fu N, Griffiths AM, Keefer L, Kohut SA, Kroeker KI, Lawrence S, Lee K, Mack DR, Walters TD, de Guzman J, Tersigni C, Miatello A, Benchimol EI. Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial. BMC Gastroenterol. 2022 May 18;22(1):251. doi: 10.1186/s12876-022-02307-9.
PubMed 35585484
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
- ClinicalTrials.gov ID
- NCT05221281
- Acronym / sponsor ID
- 1000078476
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Adolescent Development, Transition, Mental Health Wellness 1
- Keywords
- Transition from Pediatric to Adult Care, Health Services Research, Adolescent Medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Canada, The Leona M. and Harry B. Helmsley Charitable Trust, The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation, The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2022 (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: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada.
Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program.
Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Multimodal intervention consisting of four core components. | Experimental | Behavioral: Multimodal intervention consisting of four core componentsCore Component 1: Individualized Assessment Core Component 2: Transition Facilitation with a Navigator Core Component 3: Participant Skills-building Core Component 4: Structured Educational eLearning Curriculum |
| Control: Standard of care | Other | Behavioral: Standard of careRoutine Care |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 16-17.5 years
- Diagnosed with IBD diagnosed using standard criteria
- Ability to speak/read English at a functional (Grade 8) level
- Intention to reside in Canada after transfer to adult care
- Ability to use a smartphone or personal computer for the virtual intervention
Key exclusion criteria (2 listed)
- Do not speak English fluently
- Intention to leave Canada after graduation from high school
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 |
|---|---|---|
| Multimodal intervention consisting of four core componentsCore Component 1: Individualized Assessment: Each participant will undergo individualized assessment of their biopsychosocial risk profile (PIBD INTERMED), self-efficacy (IBD-SES-A), function (IBD-DI), transition readiness (TRAQ) and IBD knowledge (IBD-KID2), and depression, anxiety and activation. Core Component 2: Transition Navigator: Participants will be assigned a transition navigators, who will have knowledge of IBD, an understanding of the care pathway involved in transitioning IBD patients, and the skills and ability to provide psychosocial support. Core Component 3: Participant Skills-building: Skills-building materials delivered virtually. Navigators will also be trained as motivational coaches and will lead separate personalized virtual sessions targeting individual skills that have been identified as deficient during the assessment phase. Core Component 4: eLearning Curriculum: Organized online eLearning modules with reinforcement of knowledge by the navigators. | Behavioural | Intervention: Multimodal intervention consisting of four core components. |
| Standard of careAlso: ControlThe control group will be provided a standardized version of routine care for transition. In addition to recruiting centers' standard of care, all participating centers will implement the following transition interventions: 1. A written letter explaining the goals of transition to the patient and family. 2. Completion of age-appropriate checklists to ensure adolescents are meeting milestones of transition (developed by the TRACC Network).51 3. Annual online live educational webinars on transition and adolescent issues (hosted by the CIDsCaNN Education Committee). 4. Completion of the Pediatric INTERMED,52 with appropriate biopsychosocial intervention. 5. Completion of a transfer-of-care summary letter sent to the receiving adult gastroenterologist using a standardized letter template.53 The Control Group may also receive any interventions currently in place in their participating care center, but will not receive the formal 4-component intervention described below. | Behavioural | Control: Standard of care |
Primary outcome
IBD Disability Index (IBD-DI)
Time frame: 3 years
Ordinal variable that measures participant functioning as the primary outcome. IBD-DI was selected as a validated measure of overall disability, functioning, and health. The primary outcome will be measured 3 years after enrollment.
24 secondary outcomes
Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: 3 years
Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: Up to 24 months (at time of transfer to adult care)
Transition Success Scores (TSS)
Time frame: 3 years
Transition Success Scores (TSS)
Time frame: Up to 24 months (at time of transfer to adult care)
Pediatric IBD INTERMED
Time frame: 3 years
Pediatric IBD INTERMED
Time frame: Up to 24 months (at time of transfer to adult care)
IBD-KID2
Time frame: 3 years
IBD-KID2
Time frame: Up to 24 months (at time of transfer to adult care)
IBDQ-32
Time frame: 3 years
IBDQ-32
Time frame: Up to 24 months (at time of transfer to adult care)
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Time frame: 3 years
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Time frame: Up to 24 months (at time of transfer to adult care)
Physician Global Assessment (PGA)
Time frame: 3 years
Physician Global Assessment (PGA)
Time frame: Up to 24 months (at time of transfer to adult care)
Fecal calprotectin
Time frame: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Time frame: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Time frame: Up to 24 months (at time of transfer to adult care)
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time frame: 3 years
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time frame: Up to 24 months (at time of transfer to adult care)
Emergency department visit after 18th birthday (yes/no)
Time frame: 3 years
Number of emergency department visits after 18th birthday
Time frame: 3 years
Hospitalization after 18th birthday (yes/no)
Time frame: 3 years
Number of outpatient visits to a gastroenterologist after 18th birthday
Time frame: 3 years
IBD Disability Index (IBD-DI)
Time frame: Up to 24 months (at time of transfer to adult care)
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 24 Apr 2026.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 39382077Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
- Derived from this study: PubMed 35585484Bollegala N, Barwick M, Fu N, Griffiths AM, Keefer L, Kohut SA, Kroeker KI, Lawrence S, Lee K, Mack DR, Walters TD, de Guzman J, Tersigni C, Miatello A, Benchimol EI. Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial. BMC Gastroenterol. 2022 May 18;22(1):251. doi: 10.1186/s12876-022-02307-9.
- Individual participant dataSharing planned: No. * Location of the repository - OSF.io or journal (planned) * Administrators for the repository Since we are not sure which journals we will submit to at this time, we cannot comment on the location/administrators for the repository. * De-identified study data plans - At a minimum, research journals are asking that authors share a 'minimal data set' for submission. This is normally defined as the minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods. This is what will be shared with journals upon submission. * Privacy protections for stored study data - Only de-identified study data will be shared with the open access repository. Submission to research journals has been outlined on the participant consent form.
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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.
Eric I Benchimol, MD, PhD principal investigator
The Hospital for Sick Children
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention consisting of four core components in people with Inflammatory Bowel Diseases and Crohn Disease, run by The Hospital for Sick Children at 3 sites 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 5 inclusion and 2 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
IBD Disability Index (IBD-DI) (time frame: 3 years). 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 NCT05221281, which also lists 3 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 24 Apr 2026.