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Completed

NCT Number: NCT02902016

Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies

This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut

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Key information

Conditions

Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Carotid Intimal Medial Thickness 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects undergoing gastroduodenal endoscopy for digestive cancer screening
  • Subjects undergoing gastroduodenal endoscopy for ulcerative gastroduodenal diseases
  • Subjects undergoing gastroduodenal endoscopy for epigastric pains
  • Subjects undergoing gastroduodenal endoscopy for gastroesophageal reflux diseases

Exclusion criteria

  • Subjects with macroscopic duodenal lesions detected at endoscopy
  • Subjects suffering from coeliac disease
  • Subjects suffering from atrophic gastritis
  • Subjects who use anticoagulant
  • Pregnancy or breast feeding

Treatment and study plan

GED

Drug

Four duodenal biopsies will be collected. Two biopsies will stimulated with GED (PPARgamma modulator) ex vivo during 6 hours. Two biopsies will be unstimulated (control).

Primary outcomes

  1. LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM)

    Time frame: 2 years

Secondary outcomes

  1. LCT mRNA expression measured by quantitative RT-PCR in primary intestinal epithelial cells (isolated from duodenal biopsies) stimulated with a new PPARgamma agonist (GED, 1mM)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • French National Society of Gastroenterology
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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