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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02902016

Enrollment

Registered

2016-09-15

Start date

2015-07-16

Completion date

2017-09-30

Last updated

2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose Intolerance

Keywords

PPARgamma, Lactose intolerance, Lactase

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

Interventions

DRUGGED

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026