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Completed

NCT Number: NCT05309330

Virtual Celiac Symptoms Study in Adults and Teenagers

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda

Lexington, Massachusetts, 02421, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
  • Speaks and reads English.
  • Lives in the US (participant reported).

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2022
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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