- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Örebro County
-
Örebro, Örebro County, Sweden, 70182
- Örebro University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbial composition of rectal and faecal microbiota
Time Frame: 1 day
|
16S rRNA-based next generation sequencing
|
1 day
|
Metabolic profile in faecal samples along the intestinal tract
Time Frame: 1 day
|
metabolomics
|
1 day
|
Gene expression of transporters for bacterial products in mucosal biopsies along the colon
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Brummer, Prof., Region Örebro County, Örebro University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SpIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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