Trial reportScientific reports2017
Randomized clinical trial: Effective gluten degradation by Aspergillus niger-derived enzyme in a complex meal setting.
Trial report in Scientific reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.
- European Society for the Study of Coeliac Disease (ESsCD) 2025 Updated Guidelines on the Diagnosis and Management of Coeliac Disease in Adults. Part 2: Management, Follow-Up, and Complex Disease Courses.United European gastroenterology journal · 2026Guideline
- Novel probiotic preparation withMicrobiology spectrum · 2024Trial
- Acute Microbial Protease Supplementation Increases Net Postprandial Plasma Amino Acid Concentrations After Pea Protein Ingestion in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.The Journal of nutrition · 2024Trial
- Effect ofWorld journal of gastroenterology · 2024Trial
- The expanding role of protease therapeutics (2012-2026): from replacement therapies to immune system modulation and beyond.The Biochemical journal · 2026Review
- Harnessing gut microbiome enzymes:Microbiology spectrum · 2026Article
- Beyond gluten-free diet: Novel therapeutic frontiers in celiac disease armamentarium.World journal of gastrointestinal pharmacology and therapeutics · 2026Review
- Targeted enzymatic therapy for coeliac disease.EMBO molecular medicine · 2026Article
- Review
- From gluten to therapeutics: molecular mechanisms of celiac disease and emerging alternatives to the gluten-free diet.Frontiers in pharmacology · 2026Review
- Review
- Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.Nutrients · 2025Review
- The Effects of a Microbial Enzyme Mixture on Macronutrient Hydrolysis in a Static Simulation of Oro-Gastric Digestion That Models Human Digestive Senescence.Foods (Basel, Switzerland) · 2025Article
- Celiac Disease: Beyond Diet and Food Awareness.Foods (Basel, Switzerland) · 2025Review
- Advances in understanding and managing celiac disease: Pathophysiology and treatment strategies.World journal of gastroenterology · 2024Article
- Digesting gluten with oral endopeptidases to improve the management of celiac disease.World journal of gastroenterology · 2024Article
- New Insights on Genes, Gluten, and Immunopathogenesis of Celiac Disease.Gastroenterology · 2024Review
- Non-Host Factors Influencing Onset and Severity of Celiac Disease.Gastroenterology · 2024Review
- Article
- Safety and Tolerability of Microbial Inulinase Supplementation in Healthy Adults: A Randomized, Placebo-Controlled Trial.Gastro hep advances · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Aspergillus niger-derived prolyl endoprotease (AN-PEP) has previously been shown to degrade gluten in healthy subjects when added to an intragastrically infused meal. The current study investigated the efficacy of AN-PEP in a physiological meal setting. In this randomized placebo-controlled crossover study, 18 gluten-sensitive subjects consumed a porridge containing 0.5 g gluten together with two tablets either containing a high or low dose of AN-PEP, or placebo. Gastric and duodenal content was sampled over 180 minutes, and areas under the curve of gluten concentrations were calculated. The primary outcome, i.e. success rate of high dose AN-PEP defined as at least 50% gluten degradation compared to placebo in the duodenum, was achieved in 10 of 13 comparisons. In the stomach, gluten levels were reduced from 176.9 (median, interquartile range 73.5-357.8) to 22.0 (10.6-50.8, p = 0.001) in the high dose and to 25.4 μg × min/ml (16.4-43.7, p = 0.001) in the low dose. In the duodenum, gluten levels were reduced from 14.1 (8.3-124.7) in the placebo to 6.3 (3.5-19.8, p = 0.019) in the high dose and to 7.4 μg × min/ml in the low dose (3.8-12.0, p = 0.015). Thus even in a physiological meal setting, AN-PEP significantly degraded most gluten in the stomach before it entered the duodenum.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.