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Diabetes MellitusJE/COL-MIMENCT05186389

Jejunal Luminal and Colonic Mucosa-Associated Microbiota in Metabolic Diseases: Methods, Identification and Causalities

An observational study of Diabetes Mellitus and Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Obesity, Metabolic Disease
How many people
30 participants
Where
1 siteFrance
Study dates
17 Jan 2022to 17 Jan 2024
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 1. Control Group 15 non-obese participants considered "metabolically-healthy" : "control group" 2. Obese group (Ob) 15 severely obese participants, candidates for bariatric surgery, but without T2D: "obese group" (Ob) 3. Obese and Type 2 Diabetes group (ObD) 15 participants who are both severely obese, candidates for bariatric surgergy and diagnosed with T2D: "obese and diabetic group" (ObD).

Who may be able to join

  • General Inclusion Criteria:
  • Aged between 18 and 60 years;
  • Ability to understand and provide informed consent (in French);
  • Ability and willingness to meet the required schedule and study procedures;
  • Group-Specific Inclusion Criteria:
  • Control Group
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  • Inclusion criteria for the participants from the Control group are:
  • Presence of Gastroesophageal Reflux Disease symptoms or gastric discomfort.
  • BMI [19kg/m² < BMI <25 kg/m²]
  • Match age and sex to the patients from the Ob and ObD groups.
  • Only patients with normal glucose tolerance (NGT), glucose tolerance (IGT) and/or fasting glucose (IFG) and an HbA1c < 6.5 % will be included in this group.
  • Ob Group
  • 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) :
  • IMC ≥ 40 kg/m² without comorbidities Or IMC≥ 35 kg/m² with at least one obesity-related comorbidity (i.e.: Hypertension, Dyslipidemia, Obstructive Sleep Apnea, Joints Disease, non-alcoholic steatohepatitis, excluding T2D)
  • Weight stable for at least 2 months
  • No treatment for metabolic health complications, no previous obesity surgery, no obesity treatment drug.
  • No monogenic form of obesity (Hebebrand et al., 2017)
  • ObD Group
  • Inclusion criteria for the participants from ObD groups are:
  • Candidate for bariatric surgery with T2D
  • At least one obesity-related comorbidity including T2D
  • Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) or
  • Participants with HbA1c ≥ 6.5% (48 mmol/mol)
  • All stages of albuminuria

Who cannot join

  • General Non-inclusion Criteria:
  • Treatment for the previous 12 week that could
  • alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives),
  • acidity (PPI, H2RA)
  • microbial population (e.g.: antibiotics, probiotics)
  • immunosuppressants (eg: calcineurin inhibitors, corticosteroids, biological agents, etc.).
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  • use of weight-loss drug or dietary intervention aiming to lose weight;
  • Altered anatomy of the esophagus, stomach, small or large intestine due to prior gastrointestinal surgery (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment) or other reasons;
  • Any abdominal or pelvic surgery within the past 3 months;
  • Diverticulitis, diverticular stricture, or other intestinal strictures.
  • Intestinal resection of the gastrointestinal tract
  • Previous history of gastric bezoar or gastroparesis
  • Acute or chronic inflammatory bowel disease or infections diseases (i.e.: VHC, VHB, VIH, etc.)
  • Abdominal or pelvic radiotherapy or abdominal cancer
  • Colorectal cancer, either known or not
  • Dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder
  • Organ Transplantation and patients on Immunosuppressive Therapy
  • Severe kidney failure and/or patients on dialysis therapy (serum creatinine > 150 μmol/l or eGFR < 60 ml/min per 1.73 m2 body surface area)
  • CVD, endocrine, renal or other chronic disease likely to affect motility.
  • Colon cleansing preparation during the last 1 month
  • No < 3 bowel movements per week
  • Females of childbearing age who do not practice birth control and/or are pregnant or lactating
  • Participants non-affiliated to the French national health scheme
  • Participants who are already included in a clinical study which implies testing any pharmaceutical drug.
  • Participants who do not understand the research procedures those who are institutionalized, or who unable to give informed consent
  • Participants placed under legal protection
  • Patients with drug addiction
  • Antibiotherapy 3 months preceding the endoscopy
  • Weight variation (diminution or increase) > 5kg in the last 3 months
  • Specific non-inclusion Criteria
  • Ob and ObT2D Group
  • Usual contraindication for bariatric surgery;

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Privé des Peupliers, 8 Place de l'Abbé Georges Hénocque, 75013

    Paris

Other trials in France

About this study

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).

Read more

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.

Keywords
microbiota, endoscopy, colonoscopy, obesity, type II diabetes
Medical subject headings
Diabetes Mellitus, Obesity, Metabolic Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05186389
Study groupRoleWhat they receive
"Control Group"15 non-obese participants considered "metabolically-healthy" : "control group"
Obese group (Ob)15 severely obese participants, candidates for bariatric surgery, but without T2D: "obese group" (Ob)
Obese and Type 2 Diabetes group (ObD)15 participants who are both severely obese, candidates for bariatric surgergy and diagnosed with T2D: "obese and diabetic group" (ObD).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metagenomic analysis

    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.

    Measured: 1 month

Secondary outcomes (1)

  1. Clinical associations with metagenomic analysis

    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:

    • Metabolic phenotype (serum)
    • Systemic inflammation status and Entero and Neuroendocrine markers (serum and biopsies)
    • Anthropometric measurements
    • Histological analysis of the jejunal biopsy obtained during endoscopy and colonoscopy
    • Lifestyle factors collected through lifestyle questionnaires:
    • Medical history questionnaires
    • Dietary patterns
    • Physical activity
    • Smoking habits
    • Psycho-emotional health and Quality of Life

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion17 Jan 2024
  4. Study completion17 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
30 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186389
Sponsor's protocol ID
C20-86
Acronym
JE/COL-MIME
Status last verified
Jan 2025
First submitted
7 Dec 2021
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Steinbach E, Belda E, Alili R, Adriouch S, Dauriat CJG, Donatelli G, Dumont JL, Pacini F, Tuszynski T, Pelloux V, Jacques F, Creusot L, Coles E, Taillandier P, Vazquez Gomez M, Masi D, Mateo V, Andre S, Kordahi M, Rouault C, Zucker JD, Sokol H, Genser L, Chassaing B, Le Roy T, Clement K. Comparative analysis of the duodenojejunal microbiome with the oral and fecal microbiomes reveals its stronger association with obesity and nutrition. Gut Microbes. 2024 Jan-Dec;16(1):2405547. doi: 10.1080/19490976.2024.2405547. Epub 2024 Oct 7.

    PubMed 39679619

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Obesity, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metagenomic analysis (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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