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CompletedNCT02902016Updated Oct 17, 2018

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

An interventional study of GED in Lactose Intolerance, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Lactose Intolerance

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Keywords

  • PPARgamma
  • Lactose intolerance
  • Lactase
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Lactase expression induction by GED

    Drug: GED

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).

05

What researchers measure

Primary outcomes

  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 outcomes

  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

06

Study locations

1 site
  • CHRU, Hôpital Claude Huriez
    Lille, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02902016
Lead sponsor
University Hospital, Lille
Collaborators
French National Society of Gastroenterology, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Sep 15, 2016
Start date
Jul 16, 2015
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Oct 17, 2018

Study contacts

Pierre Desreumaux, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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