Trial reportDigestive diseases and sciences2017
Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet.
Trial report in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01917630 (A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet), which is not on this map. Cited by 38 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Who cites it
38 citing papers in PubMed, 80 citations in OpenAlex.
- Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge.Gastroenterology · 2022Trial
- Beyond gluten-free diet: Novel therapeutic frontiers in celiac disease armamentarium.World journal of gastrointestinal pharmacology and therapeutics · 2026Review
- Review
- From gluten to therapeutics: molecular mechanisms of celiac disease and emerging alternatives to the gluten-free diet.Frontiers in pharmacology · 2026Review
- Living Gluten-Free in Romania: A National Cross-Sectional Study of Dietary Adherence in Clinically Diagnosed and Self-Reported Cases.Nutrients · 2025Article
- Review Article: Novel Enzyme Therapy Design for Gluten Peptide Digestion Through Exopeptidase Supplementation.Alimentary pharmacology & therapeutics · 2025Review
- Beyond the gluten-free diet: Innovations in celiac disease therapeutics.World journal of gastroenterology · 2024Review
- Coeliac Disease in Children-A Clinical Review Including Novel Treatment Agents.Medicina (Kaunas, Lithuania) · 2024Review
- A Composite Morphometric Duodenal Biopsy Mucosal Scale for Celiac Disease Encompassing Both Morphology and Inflammation.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024Article
- Review
- Gluten-Free Diet and Other Celiac Disease Therapies: Current Understanding and Emerging Strategies.Nutrients · 2024Review
- Specificity Enhancement of Glutenase Bga1903 toward Celiac Disease-Eliciting Pro-Immunogenic Peptides via Active-Site Modification.International journal of molecular sciences · 2023Article
- Emerging Pharmaceutical Therapies to Address the Inadequacy of a Gluten-Free Diet for Celiac Disease.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Article
- Celiac disease: mechanisms and emerging therapeutics.Trends in pharmacological sciences · 2023Review
- Old and New Adjunctive Therapies in Celiac Disease and Refractory Celiac Disease: A Review.International journal of molecular sciences · 2023Review
- New Developments in Celiac Disease Treatment.International journal of molecular sciences · 2023Review
- A Comprehensive Review of the Neurological Manifestations of Celiac Disease and Its Treatment.Diseases (Basel, Switzerland) · 2022Review
- Review
- Recombinant Cathepsin L ofInternational journal of molecular sciences · 2022Article
Corrections and comments
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Authors and funding
4 authors at 4 institutions in 1 country.
Funding
Abstract
BACKGROUND AND
aimsCeliac disease (CD) is a widespread condition triggered by dietary gluten and treated with a lifelong gluten-free diet (GFD); however, inadvertent exposure to gluten can result in episodic symptoms. A previous trial of latiglutenase (clinicaltrials.gov; NCT01917630), an orally administered mixture of two recombinant gluten-specific proteases, was undertaken in symptomatic subjects with persistent injury. The primary endpoint for histologic improvement was not met, presumably due to a trial effect. In this post hoc analysis, we investigated the efficacy of latiglutenase for reducing symptoms in subgroups of the study participants based on their seropositivity.
methodsThe study involved symptomatic CD patients following a GFD for at least one year prior to randomization. Patients were treated for 12 weeks with latiglutenase or placebo. Of 398 completed patients, 173 (43%) were seropositive at baseline. Symptoms were recorded daily, and weekly symptom scores were compiled. p values were calculated by analysis of covariance.
resultsA statistically significant, dose-dependent reduction was detected in the severity and frequency of symptoms in seropositive but not seronegative patients. The severity of abdominal pain and bloating was reduced by 58 and 44%, respectively, in the cohort receiving the highest latiglutenase dose (900 mg, n = 14) relative to placebo (n = 54). Symptom improvement increased from week 6 to week 12. There was also a trend toward greater symptom improvement with greater baseline symptom severity.
conclusionsSeropositive CD patients show symptomatic improvement from latiglutenase taken with meals and would benefit from the availability of this treatment.
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