Skip to main content
OpenTrials
Completed

NCT Number: NCT03918330

Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro university

Örebro, Örebro County, 70182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Major relevant allergies (e.g. food allergy, multiple allergies)
  • Chronic pain syndromes (e.g. fibromyalgia)
  • Chronic fatigue syndrome
  • Obesity (body mass index>30) or metabolic syndrome
  • Antimicrobial treatment or prophylaxis within the last 3 months
  • Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors
  • Females who are pregnant or breast-feeding
  • Known clinically significant abnormal laboratory values
  • Abuse of alcohol or drugs
  • Probiotic intake within the last 6 weeks
  • Bowel cleansing within the last 6 months
  • Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Treatment and study plan

Primary outcomes

  1. 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

  1. Microbial composition of rectal and faecal microbiota

    Time frame: 1 day

    16S rRNA-based next generation sequencing

  2. Metabolic profile in faecal samples along the intestinal tract

    Time frame: 1 day

    metabolomics

  3. Gene expression of transporters for bacterial products in mucosal biopsies along the colon

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Region Örebro County

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2024
First posted
Apr 17, 2019
Registry last updated
Mar 27, 2025

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.

Published trials that share one or more normalized conditions with this study.