Virtual Celiac Symptoms Study in Adults and Teenagers

March 8, 2023 updated by: Takeda

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • Takeda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with CeD in the United States.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with CeD
Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period.
Other: No Intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 weeks
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).
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure
Time Frame: Up to 12 weeks
This will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18).
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
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).
Up to 12 weeks
Number of Participants With Healthcare Resource Utilization (HCRU)
Time Frame: Up to 12 weeks
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).
Up to 12 weeks
Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire
Time Frame: Up to 12 weeks
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).
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Actual)

March 4, 2023

Study Completion (Actual)

March 4, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-101-5001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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