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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902016
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
French National Society of Gastroenterology
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Lactose Intolerance Drug: GED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies
Actual Study Start Date : July 16, 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactase expression induction by GED Drug: 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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902016


Locations
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France
CHRU, Hôpital Claude Huriez
Lille, France
Sponsors and Collaborators
University Hospital, Lille
French National Society of Gastroenterology
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Pierre Desreumaux, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02902016    
Other Study ID Numbers: 2013_68
2015-A00259-40 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Lille:
PPARgamma
Lactose intolerance
Lactase
Additional relevant MeSH terms:
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Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases