Back to resultsModulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies
Primary Purpose
Lactose Intolerance
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GED
Sponsored by
About this trial
This is an interventional basic science trial for Lactose Intolerance focused on measuring PPARgamma, Lactose intolerance, Lactase
Eligibility 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
Sites / Locations
- CHRU, Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactase expression induction by GED
Arm Description
Outcomes
Primary Outcome Measures
LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02902016
First Posted
September 12, 2016
Last Updated
October 12, 2018
Sponsor
University Hospital, Lille
Collaborators
French National Society of Gastroenterology, Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02902016
Brief Title
Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies
Official Title
Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 16, 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
French National Society of Gastroenterology, Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
Keywords
PPARgamma, Lactose intolerance, Lactase
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactase expression induction by GED
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GED
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Desreumaux, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies
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