Clinical TrialID 7917
RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.
NCT05803408
Celiac Disease|Gluten Sensitivity|Gluten Allergy|Gluten Enteropathy
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Herb: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7917
- Evidence Id
- 7917
- Core Evidence Id
- 7917
- Source Clinical Trial Id
- 7914
- Herb2 Clinical Trial Id
- HBCT007914
- Nct Id
- NCT05803408
- Title
- RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Celiac Disease|Gluten Sensitivity|Gluten Allergy|Gluten Enteropathy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
- Intervention
- OTHER: gluten-free oats
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Single
- Intervention Purpose
- Other
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 50
- Outcome Measure
- Better symptom control, To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving better symptom control (change in Celiac Disease Gastrointestinal Symptom Rating Scale scores; range 15-115; lower the score, the better the outcome) at 3- and 6-month follow-up, 3-6 months|tTG antibody levels, To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: Change in tTG antibody levels at 6-month follow-up, 6 months|improvement of nutritional status, To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement of nutritional status (reduce % body fat mass), 6 months|improvement in quality of life (change in Celiac Disease Quality of Life scores), To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement in quality of life (change in Celiac Disease Quality of Life scores, 20-100, lower the score better the outcome) at 3- and 6-month follow-up, 3-6 months|Food insecurity, Food insecurity will be assessed through Household Food Security Survey Module (HFSSM), 6 months
- Sponsor Collaborator
- McMaster University
- Funded By
- OTHER
- Location
- McMaster University Medical Center, Hamilton, Ontario, L8S2H1, Canada
- Other Id
- 15964
- Start Date
- 2023-06-01
- Primary Completion Date
- 2024-12
- Completion Date
- 2025-05
- First Posted
- 2023-04-07
- Results First Posted
- Last Update Posted
- 2024-03-15
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05803408
- Title Cn
- Title En
- RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.
- Bilingual Status
- semi_complete