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

NCT ID: NCT02902016

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-16

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Lactose Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lactase expression induction by GED

Group Type EXPERIMENTAL

GED

Intervention Type 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).

Interventions

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GED

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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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French National Society of Gastroenterology

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Desreumaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00259-40

Identifier Type: OTHER

Identifier Source: secondary_id

2013_68

Identifier Type: -

Identifier Source: org_study_id

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