Determination of gluten consumption in celiac disease patients on a gluten-free diet.
Study Goal
The researchers aimed to determine the extent of accidental gluten consumption among celiac disease patients adhering to a gluten-free diet.
Results Summary
The study found that celiac disease patients on a gluten-free diet inadvertently consume significant amounts of gluten (mean 150-400 mg/day, median 100-150 mg/day), enough to trigger symptoms and cause intestinal damage. Surrogate biomarkers confirmed regular gluten exposure despite dietary adherence.
Population
Celiac disease patients adhering to a gluten-free diet, including those with moderate to severe symptoms.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
gluten-free diet | increase | symptoms and persistent intestinal histologic damage | Celiac disease patients | low levels | exposed frequently to low levels of gluten | #1 |
gluten-free diet | increase | average inadvertent exposure to gluten | CD individuals on a GFD | ∼150-400 (mean) and ∼100-150 (median) mg/d | estimated to be | #2 |
gluten-free diet | increase | average inadvertent exposure to gluten | CD individuals on a GFD | ∼300-400 (mean) and ∼150 (median) mg/d | estimated to be | #3 |
gluten-free diet | increase | gluten | CD individuals with moderate to severe symptoms | >200 mg/d | ingested significantly | #4 |
gluten-free diet | increase | symptoms and perpetuate intestinal histologic damage | many individuals following a GFD | sufficient gluten | regularly consume sufficient gluten to trigger | #5 |
BACKGROUND: Celiac disease (CD) patients adhering to a gluten-free diet (GFD) are exposed frequently to low levels of gluten that contribute to symptoms and persistent intestinal histologic damage. OBJECTIVE: We analyzed prior clinical data to determine how much gluten is accidentally consumed while on a GFD. The aim was to understand the range of gluten consumption for a wide distribution of CD patients. DESIGN: A meta-analysis was conducted on data from 2 different clinical programs: 1) measurements of gluten in stool and urine in CD and non-CD populations; and 2) analysis of data from trials for the investigational therapeutic latiglutenase. The stool and urine studies included controlled gluten challenges. A calibration factor was applied that allowed normal ingestion of gluten to be computed from the urine and stool measurements. From the latiglutenase trial data, a determination of gluten consumption was made by estimating how much gluten was eliminated from patients' diets due to a trial effect that led to improved histology even in the placebo group. RESULTS: The average inadvertent exposure to gluten by CD individuals on a GFD was estimated to be ∼150-400 (mean) and ∼100-150 (median) mg/d using the stool test and ∼300-400 (mean) and ∼150 (median) mg/d using the urine test. The analyses of the latiglutenase data for CD individuals with moderate to severe symptoms indicate that patients ingested significantly >200 mg/d of gluten. CONCLUSIONS: These surrogate biomarkers of gluten ingestion indicate that many individuals following a GFD regularly consume sufficient gluten to trigger symptoms and perpetuate intestinal histologic damage.