Healthy Clinical Trial
Official title:
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
The goal of this clinical trial is to compare the gastro-intestinal biopotentials recorded with a homemade device using surface electrodes placed on the abdomen in healthy volunteers, Crohn's disease patients without fibrosis, Crohn's disease patients with fibrosis and in functional gastrointestinal disorders (FGID) patients. The main question it aims to answer is: • Is there any differences in the gastro-intestinal biopotentials between the different populations under study? It aims to answer two secondary questions: - Are the gastro-intestinal biopotentials comparable to the Harvey-Bradshaw Index, MRI and biological data for patients with Crohn's disease? - Are the gastro-intestinal biopotentials comparable to Rome IV criteria for functional gastrointestinal disorders patients? Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, the participants will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.
Diseases and disorders of the digestive tract affect a large proportion of the world's population. These disorders or diseases degrade patients' quality of life and are costly for healthcare systems. Today, it is difficult to categorize, monitor and/or prognosticate their evolution due to their unknown etiologies, the long duration of the digestion processes and unsuitable (invasive, complex or costly) examinations. However, electrophysiology holds great promise for the study of these diseases. Indeed, the organs of the digestive tract are made up of longitudinal and circular muscles which contract rhythmically and synchronously to advance the food bolus during digestion, or to cleanse the digestive tract once digestion is complete. No study has yet demonstrated the feasibility and value of measuring these bio-potentials for Functional Gastro Intestinal Disorders and Inflammatory Bowel Diseases. That's why a homemade gastro-intestinal biopotentials recorder was developped. The recorder uses surface electrodes placed on the abdomen to record this biopotentials. The investigators hypothesize that surface gastro-intestinal biopotentials differ between a population of healthy volunteers, Crohn's disease patients and FGID patients. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |