Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

NCT03918330 | Completed

• 1 other identifier: SpIM
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

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

  16S rRNA-based next generation sequencing

  1 day

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

10 healthy volunteers will be recruited via local advertisements.

You may qualify if:

• Signed informed consent
• Age: 18-65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Region Örebro County: collaborator

Study Sites (1)

Örebro university

Örebro, Örebro County, 70182, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

bacterial DNA

Study Officials

• Robert Brummer, Prof.

  Region Örebro County, Örebro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: August 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: October 10, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)