Hôpital Privé des Peupliers, 8 Place de l'Abbé Georges Hénocque, 75013
Paris, France
NCT Number: NCT05186389
This clinical study will investigate Jejunal Microbiota in Metabolic Diseases (Je-MiMe, n=45) and Colonic mucosa-associated Microbiota in Metabolic Diseases (Col-MiMe, n=45).
Each cohort (Je and Col -MiMe) is composed of three groups: participants with obesity (n=15) with obesity and with type II diabetes (n=15).
This research protocol is organized in two parts. Each part of this study will recruit 45 participants that are only recruited in one of the parts of the protocol (JE-MIME or COL-MIME). Thus, in total, the study will include 90 patients. Each part of this study is composed of 3 groups: 1) "Control Group ", 2) Obese group (Ob), 3) Obese and Type 2 Diabetes group (ObD). Control groups for part I (JE-MIME) and part 2 (COL-MIME) are composed of different participants. Each group is composed of 15 human adult volunteers for the JE-MIME study (part 1) and 15 participants for the COL-MIME study (part 2). Total number of participants is 45 for part 1, and 45 for part 2. Total number for this project is 90.
Microbiota wil be collected during an endoscopy or coloscopy which is planned as routine care for the patients.
Primary objectives are to characterize jejunal (JE-MIME, Part I of the study) and colonic mucosa-associated microbiota (COLMIME, Part II of the study) and compare both microbiota to faecal microbiota (evaluate differences and similarities between jejunal microbiota or mucus-associated microbiota and faecal microbiota).
Secondary objectives are to 1) Correlate microbiota with metabolic health and inflammatory markers; 2) Correlate microbiota with lifestyle and neuropsychological health.
Both the jejunal microbiota and mucus-associated microbiota are strong integrators of nutritional environment and intestinal health status, respectively, compared to the fecal microbiota. This study will help to better understand the physiopathology of metabolic diseases. This research could lead to finding specific microbiota members, either from the jejunal compartment or from the inner mucus layer, crucial for the promotion / protection of chronic intestinal inflammation and associated metabolic health.
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Notify Me18 year–60 year
All sexes
Observational
Paris, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for the participants from the Control group are:
Inclusion criteria
for the participants from Ob and ObD groups are:
● Candidate for bariatric surgery and meet the HAS criteria (Haute Autorité de Santé, 2009) :
Inclusion criteria
for the participants from ObD groups are:
Exclusion criteria
Time frame: 1 month
Single time point analysis of jejunal or colonic mucosal-associated and fecal microbiota.
Microbiota will be analysed through 16S rRNA gene sequencing as well as shotgun metagenomic sequencing of the different samples.
We will examine if jejunal microbiota abundance is decreased in subjects with obesity and obesity + type 2 diabetics compared to lean subjects. Based on metagenomic sequencing data, the number of bacterial genes will be estimated and compared between groups.
We will examine the distance of bacterial layer in the mucus from intestinal epithelial cells in people with T2D as compared to people without T2D and lean subjects.
Time frame: 1 month
Single time point analysis : Investigation of the correlations between jejunal microbiota or mucosal-associated microbiota and clinical parameters.
Secondary objectives are to analyse the relationship between jejunal microbiota/mucus-associated microbiota and metabolic health, inflammation, lifestyle and mental health that will be evaluated through extensive bio-clinical phenotyping and will include:
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: JE/COL-MIME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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