Virtual Celiac Symptoms Study in Adults and Teenagers

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: Celiac Disease
• Intervention / Treatment: Other: No Intervention

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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)	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	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	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)	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)	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	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

• Sponsor: Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

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: Quality of Life; Diet; Celiac Disease; Signs and Symptoms; Digestive; Gluten-Free
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• 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