NCT02902016

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

September 12, 2016

Last Update Submit

October 12, 2018

Conditions

Lactose Intolerance

Keywords

PPARgammaLactose intoleranceLactase

Outcome Measures

Primary Outcomes (1)

  • LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM)

    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)

    2 years

Study Arms (1)

Lactase expression induction by GED

EXPERIMENTAL
Drug: GED

Interventions

GEDDRUG

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).

Lactase expression induction by GED

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

MeSH Terms

Conditions

Lactose IntoleranceCarotid Intimal Medial Thickness 1

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pierre Desreumaux, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

July 16, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

FR(1)