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NCT02902016 Clinical Trial

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

Lactose Intolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02902016
Other study ID # 2013_68
Secondary ID 2015-A00259-40
Status Completed
Phase N/A
First received
Last updated
Start date July 16, 2015
Est. completion date September 2017

Study information
Verified date October 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
France CHRU, Hôpital Claude Huriez Lille

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Lille French society of Gastroenterology, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

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