Virtual Celiac Symptoms Study in Adults and Teenagers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. At least 12 years of age or older. 2. Diagnosed with CeD for at least 1 year. 3. For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported). 4. For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported). 5. Currently following a gluten free diet (GFD) for at least 6 months. 6. Has experienced symptoms believed by the participant to be CeD related in the last 3 months. 7. Has daily access to a smartphone as well as internet/Wi-Fi/cellular data. 8. Speaks and reads English. 9. Lives in the US (participant reported).

Exclusion Criteria:

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05309330
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Participants with CeD

Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period.

Interventions

Other: - No Intervention

This is a non-interventional study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Takeda, Lexington, Massachusetts

Status

Recruiting

Address

Takeda

Lexington, Massachusetts, 02421

Site Contact

Study Contact Takeda

TrialDisclosures@takeda.com

877-825-3327

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