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

Not Applicable

Completed

• Conditions: Lactose Intolerance
• Interventions: Drug: GED

• Registration Number: NCT02902016
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-16
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactase expression induction by GED	GED	-

Primary Outcome Measures

Name	Time	Method
LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM)	2 years

Secondary Outcome Measures

Name	Time	Method
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)	2 years

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France