Healthy SubjectsNCT03918330
Spatial Analysis of the Intestinal Microbiota in Healthy Subjects
An observational study of Healthy Subjects, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2018to 10 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 healthy volunteers will be recruited via local advertisements.
Who may be able to join
- Signed informed consent
- Age: 18-65 years
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
Microbial composition of rectal and faecal microbiota
16S rRNA-based next generation sequencing
Measured: 1 day
Metabolic profile in faecal samples along the intestinal tract
metabolomics
Measured: 1 day
Gene expression of transporters for bacterial products in mucosal biopsies along the colon
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Aug 2018
- Primary completion28 Feb 2019
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Robert Brummer, Prof., Principal investigator, Region Örebro County, Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918330
- Sponsor's protocol ID
- SpIM
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Analysis of the Intestinal Microbiota in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03918330
- Acronym / sponsor ID
- SpIM
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 healthy volunteers will be recruited via local advertisements.
Key inclusion criteria (2 listed)
- Signed informed consent
- Age: 18-65 years
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Microbial composition of rectal and faecal microbiota
Time frame: 1 day
Metabolic profile in faecal samples along the intestinal tract
Time frame: 1 day
Gene expression of transporters for bacterial products in mucosal biopsies along the colon
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Brummer, Prof. principal investigator
Region Örebro County, Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Örebro University, Sweden at 1 site in Sweden.
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 2 inclusion and 22 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 27 Mar 2025. 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 Sweden. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.