Celiac DiseaseNCT05309330
Virtual Celiac Symptoms Study in Adults and Teenagers
An observational study of Celiac Disease, run by Takeda at 1 site in United States.
Trial summary
The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Celiac Disease
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 4 Mar 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with CeD in the United States.
Who may be able to join
- At least 12 years of age or older.
- Diagnosed with CeD for at least 1 year.
- For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
- For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
- Currently following a gluten free diet (GFD) for at least 6 months.
- Has experienced symptoms believed by the participant to be CeD related in the last 3 months.
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- Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
- Speaks and reads English.
- Lives in the US (participant reported).
Who cannot join
- 1. Currently involved or planning to be involved in any clinical studies with an investigational drug, surgical procedure, or gluten challenge over the 3-month observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey
The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required.
Read the detailed description
This is an observational, prospective study to measure symptoms and impacts of CeD.
This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately 400 participants.
The data will be prospectively collected, via a self-reported ePRO platform accessible by smartphone.
This virtual study will be conducted in the United States.
- Conditions
- Celiac Disease
- Being tested
- No Intervention
- Keywords
- Celiac Disease, Signs and Symptoms, Digestive, Quality of Life, Diet, Gluten-Free
- Medical subject headings
- Celiac Disease, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with CeD | Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
The CDSD is a celiac specific symptom assessment tool administered daily. The symptoms measured will include diarrhea, abdominal pain, bloating, nausea/vomiting, number of bowel movements and tiredness. Presence and count of each symptom will be reported for the overall sample as well as separately for adults (age greater than or equal to [>=] 18) and adolescents (age >=12 less than [<] 18).
Measured: Up to 12 weeks
Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms
Non-GI symptoms include: Headache, Brain fog (feeling confused or disorganized, or finding it hard to put thoughts into words), Dermatitis herpetiformis (DH) or other rash (suspected to be related to gluten exposure), Joint/body pain (suspected to be related to gluten exposure), Irritability (feeling easily upset or frustrated), Mouth sores/canker sores, and others. Presence/count of each symptom will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18).
Measured: Up to 12 weeks
Secondary outcomes (4)
Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure
This will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18).
Measured: Up to 12 weeks
Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2)
QoL will be measured using SF-12v2. SF-12 is a 12-item self-report that assesses the impact of health on an individual's everyday life. Average SF-12 scores will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18).
Measured: Up to 12 weeks
Number of Participants With Healthcare Resource Utilization (HCRU)
Participants reporting the number of hospitalizations, emergency room (ER) visits, and outpatient/urgent care visits they had in the previous week. HCRU will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18).
Measured: Up to 12 weeks
Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire
WPAI measures the effect of general health and symptom severity on work/schoolwork productivity and regular activities during the past seven days. Average WPAI scores will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start16 Aug 2022
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309330
- Sponsor's protocol ID
- TAK-101-5001
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey
- ClinicalTrials.gov ID
- NCT05309330
- Acronym / sponsor ID
- TAK-101-5001
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Signs and Symptoms, Digestive, Quality of Life, Diet, Gluten-Free
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 4 Apr 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.
The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required.
Detailed description
This is an observational, prospective study to measure symptoms and impacts of CeD.
This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately 400 participants.
The data will be prospectively collected, via a self-reported ePRO platform accessible by smartphone.
This virtual study will be conducted in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CeD | – | Other: No InterventionParticipants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with CeD in the United States.
Key inclusion criteria (9 listed)
- At least 12 years of age or older.
- Diagnosed with CeD for at least 1 year.
- For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
- For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
- Currently following a gluten free diet (GFD) for at least 6 months.
Key exclusion criteria (1 listed)
- 1. Currently involved or planning to be involved in any clinical studies with an investigational drug, surgical procedure, or gluten challenge over the 3-month observation period.
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 |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Participants with CeD |
Primary outcome
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
Time frame: Up to 12 weeks
The CDSD is a celiac specific symptom assessment tool administered daily. The symptoms measured will include diarrhea, abdominal pain, bloating, nausea/vomiting, number of bowel movements and tiredness. Presence and count of each symptom will be reported for the overall sample as well as separately for adults (age greater than or equal to [>=] 18) and adolescents (age >=12 less than [<] 18).
Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms
Time frame: Up to 12 weeks
Non-GI symptoms include: Headache, Brain fog (feeling confused or disorganized, or finding it hard to put thoughts into words), Dermatitis herpetiformis (DH) or other rash (suspected to be related to gluten exposure), Joint/body pain (suspected to be related to gluten exposure), Irritability (feeling easily upset or frustrated), Mouth sores/canker sores, and others. Presence/count of each symptom will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18).
4 secondary outcomes
Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure
Time frame: Up to 12 weeks
Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2)
Time frame: Up to 12 weeks
Number of Participants With Healthcare Resource Utilization (HCRU)
Time frame: Up to 12 weeks
Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Up to 12 weeks
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 10 Mar 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
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 Celiac Disease, run by Takeda at 1 site in United States.
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 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: finished, as of the sponsor's last update on 10 Mar 2023. 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 United States. 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?
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD) (time frame: Up to 12 weeks). The study lists 2 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 10 Mar 2023.