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CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.

 

The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.

© ulkan/Thinkstock
The participants attended the test site for 3 days. At each visit, they ate porridge containing approximately 0.5 g of gluten in the form of two crumbled wheat cookies. They were randomized to consume two tablets that contained 160,000 PPI of AN-PEP, 80,000 PPI, or placebo along with the cookies.

The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.

After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.

By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.

Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.

AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.

 

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CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.

 

The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.

© ulkan/Thinkstock
The participants attended the test site for 3 days. At each visit, they ate porridge containing approximately 0.5 g of gluten in the form of two crumbled wheat cookies. They were randomized to consume two tablets that contained 160,000 PPI of AN-PEP, 80,000 PPI, or placebo along with the cookies.

The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.

After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.

By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.

Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.

AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.

 

 

CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.

 

The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.

© ulkan/Thinkstock
The participants attended the test site for 3 days. At each visit, they ate porridge containing approximately 0.5 g of gluten in the form of two crumbled wheat cookies. They were randomized to consume two tablets that contained 160,000 PPI of AN-PEP, 80,000 PPI, or placebo along with the cookies.

The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.

After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.

By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.

Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.

AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.

 

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Key clinical point: Consuming an enzyme tablet simultaneously with small amounts of gluten may reduce discomfort in gluten-sensitive individuals.

Major finding: On average, gluten levels in the stomach after enzyme consumption were 31 microg x min/mL in both high- and low-dose groups, vs. 281 microg x min/mL in a placebo group.

Data source: A randomized, placebo-controlled trial of 18 gluten-sensitive adults.

Disclosures: The enzyme used in the study, AN-PEP, was provided by the Dutch company DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.