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Clinical Trials/NCT03918330
NCT03918330
Completed
Not Applicable

Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

Örebro University, Sweden1 site in 1 country10 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Örebro University, Sweden
Enrollment
10
Locations
1
Primary Endpoint
Differences in the composition of the microbiota in luminal and mucosal samples along the large intestine Composition of the microbiota in luminal as well as mucosal samples
Status
Completed
Last Updated
last year

Overview

Brief Summary

Research on the human intestinal microbiota is common as there is rising evidence of its influence on host physiology and several diseases. Predominantly, it has been based on analyses of faecal samples because of their easy sampling. A minority of studies investigated the gut microbiota using mucosal samples. Not much is known about the spatial differences in microbiota composition along the large bowel. The spatial differences of the gut microbiota without preparation of the bowel have not been analysed yet. Furthermore, the composition of the microbiota of the luminal gut content has not been analysed yet.

This study aims to gain knowledge of the microbial composition of luminal and mucosal samples at different segments of the lower gastrointestinal tract: ileum, caecum, ascending colon, transverse colon, descending colon, sigmoid colon and rectum, as well as of rectal swabs and faecal samples.

Detailed Description

The investigators aim to evaluate complete colonoscopies from 10 healthy subjects. This study is used as a first explorative study of how the human gut microbiota is distributed along the lower gastrointestinal tract. No comparable studies in an uncleansed bowel have been performed so far. The number of subjects is based on other studies investigating the microbial composition of mucosal- and faecal-associated microbiota in which a sample size of 10 was enough to detect a difference. An equal number of men and women will be recruited. Drop-outs will be replaced.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
October 10, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Örebro University, Sweden
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent
  • Age: 18-65 years

Exclusion Criteria

  • Known organic gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea or constipation)
  • History of or present gastrointestinal malignancy or polyposis
  • Recent (gastrointestinal) infection (within last 6 months)
  • History of major gastrointestinal surgery (e.g. gastric bypass)
  • Eosinophilic disorders of the gastrointestinal tract
  • Current communicable disease (e.g. upper respiratory tract infection)
  • Malignant disease and/or patients who are receiving systemic anti-neoplastic agents
  • Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation
  • Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
  • Autoimmune disease and/or patients receiving immunosuppressive medications

Outcomes

Primary Outcomes

Differences in the composition of the microbiota in luminal and mucosal samples along the large intestine Composition of the microbiota in luminal as well as mucosal samples

Time Frame: 1 day

16S rRNA-based next generation sequencing

Secondary Outcomes

  • Microbial composition of rectal and faecal microbiota(1 day)
  • Metabolic profile in faecal samples along the intestinal tract(1 day)
  • Gene expression of transporters for bacterial products in mucosal biopsies along the colon(1 day)

Study Sites (1)

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