takeda/studies/attachments/CSR_Synopsis_-_English_VAzpOdS

CSR Synopsis - English

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.

Virtual Celiac Symptoms Study in Adults and Teenagers

Celiac Disease

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.

No Intervention

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

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).

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).

This will be assessed overall and separately for adults (age >=18) and adolescents (age
>=12 and <18).

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).

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).

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).

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

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.

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.

Takeda

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).

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).

This will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18).

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).

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).

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).

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

Virtual Celiac Symptoms Study in Adults and Teenagers

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Clinical Study Report Synopsis

Locations

Location

Status