Evidence map›Paper›PMID 33844694›Full record

ArticlePloS one2021

In vivo assessment of a delayed release formulation of larazotide acetate indicated for celiac disease using a porcine model.

Hiroko Enomoto, James Yeatts, Liliana Carbajal, B Radha Krishnan, Jay P Madan, Sandeep Laumas, Anthony T Blikslager, Kristen M Messenger

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
  6. Larazotide acetate: a pharmacological peptide approach to tight junction regulation.American journal of physiology. Gastrointestinal and liver physiology · 2021
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Hiroko EnomotoComparative Medicine Institute, North Carolina State University, Raleigh, NC, United States of America.
James YeattsComparative Medicine Institute, North Carolina State University, Raleigh, NC, United States of America.
Liliana CarbajalComparative Medicine Institute, North Carolina State University, Raleigh, NC, United States of America.
B Radha KrishnanInnovate Biopharmaceuticals Inc., Raleigh, NC, United States of America.
Jay P MadanInnovate Biopharmaceuticals Inc., Raleigh, NC, United States of America.
Sandeep LaumasInnovate Biopharmaceuticals Inc., Raleigh, NC, United States of America.
Anthony T BlikslagerComparative Medicine Institute, North Carolina State University, Raleigh, NC, United States of America.
Kristen M MessengerComparative Medicine Institute, North Carolina State University, Raleigh, NC, United States of America.ORCID 0000-0001-8161-4482
North Carolina State University · US

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
NIDDK NIH HHS P30 DK034987
6 · The paper itself

Abstract

There is no FDA approved therapy for the treatment of celiac disease (CeD), aside from avoidance of dietary gluten. Larazotide acetate (LA) is a first in class oral peptide developed as a tight junction regulator, which is a lead candidate for management of CeD. A delayed release formulation was tested in vitro and predicted release in the mid duodenum and jejunum, the target site of CeD. The aim of this study was to follow the concentration versus time profile of orally administered LA in the small intestine using a porcine model. A sensitive liquid chromatography/tandem mass spectrometry method was developed to quantify LA concentrations in porcine intestinal fluid samples. Oral dosing of LA (1 mg total) in overnight fasted pigs resulted in time dependent appearance of LA in the distal duodenum and proximal jejunum. Peak LA concentrations (0.32-1.76 μM) occurred at 1 hour in the duodenum and in proximal jejunum following oral dosing, with the continued presence of LA (0.02-0.47 μM) in the distal duodenum and in proximal jejunum (0.00-0.43 μM) from 2 to 4 hours following oral dosing. The data shows that LA is available in detectable concentrations at the site of CeD.

Indexed as

Administration, OralAnimalsCeliac DiseaseDrug LiberationDuodenumJejunumOligopeptidesSwinelarazotide acetateOligopeptides

Identifiers

PMID33844694
PMCPMC8041193
OpenAlexW3153173456

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.