Human MicrobiomeNCT03157687
Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation
An observational study of Human Microbiome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to 31 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy controls patients with inflammatory bowel disease patients with liver disease (liver cirrhoses) and indication for LTX-evaluation
Who may be able to join
- healthy volunteers with indication for cancer screening without gastrointestinal symptoms
- patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- patients with indication for evaluation of liver transplantation (LTX)
Who cannot join
- other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors
- antibiotic treatment within 6 weeks before gastroscopy / colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation Under Mixed Diet
This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.
Read the detailed description
A dysbiosis of human gut microbiome is discussed in the pathogenesis of many disorders, also including gastrointestinal (e.g. inflammatory bowel disease, IBD) or liver diseases (e.g. liver cirrhosis) . A detailed analysis of intestinal bacterial patterns might reveal important findings for understanding disease pathogenesis. Thereby many studies only analysed the luminal microbiome of stool samples, whereas mucosa-associated bacteria have possibly a greater impact on human health and immune system .
To determine the differences of luminal and mucosa-associated bacteria, stool and mucosa samples (via biopsies) will be collected. Thereby biopsies are taken of different intestinal locations (small intestine and colon) to detect variations along intestinal tract. An additional comparison of bacterial patterns in patients with chronic, local (IBD) and systemic inflammation (with liver cirrhosis) or without intestinal inflammations (healthy controls) should reveal the influence of microbiome on or by inflammation processes.
- Conditions
- Human Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | * Blood sampling for nutrition and inflammatory status * Stool sampling before preventive gastroscopy and colonoscopy * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma | |
| Inflammatory bowel disease (IBD) | * Blood sampling for nutrition and inflammatory status * Stool sampling before indicated gastroscopy and colonoscopy * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma | |
| Liver transplantation recipient (LTX) | * Blood sampling for nutrition and inflammatory status * Stool sampling before indicated gastroscopy and colonoscopy for evaluation of liver transplantation (LTX) * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial composition
detection of bacterial families in stool and mucosa samples
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 May 2017
- Study startJun 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157687
- Sponsor's protocol ID
- MicrobiomStudy
- Status last verified
- Jan 2021
- First submitted
- 15 May 2017
- Last updated
- 21 Feb 2022
- 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 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation Under Mixed Diet
- ClinicalTrials.gov ID
- NCT03157687
- Acronym / sponsor ID
- MicrobiomStudy
- Conditions
- Human Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 May 2017 (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.
This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.
Detailed description
A dysbiosis of human gut microbiome is discussed in the pathogenesis of many disorders, also including gastrointestinal (e.g. inflammatory bowel disease, IBD) or liver diseases (e.g. liver cirrhosis) . A detailed analysis of intestinal bacterial patterns might reveal important findings for understanding disease pathogenesis. Thereby many studies only analysed the luminal microbiome of stool samples, whereas mucosa-associated bacteria have possibly a greater impact on human health and immune system .
To determine the differences of luminal and mucosa-associated bacteria, stool and mucosa samples (via biopsies) will be collected. Thereby biopsies are taken of different intestinal locations (small intestine and colon) to detect variations along intestinal tract. An additional comparison of bacterial patterns in patients with chronic, local (IBD) and systemic inflammation (with liver cirrhosis) or without intestinal inflammations (healthy controls) should reveal the influence of microbiome on or by inflammation processes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –* Blood sampling for nutrition and inflammatory status * Stool sampling before preventive gastroscopy and colonoscopy * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma |
| Inflammatory bowel disease (IBD) | – | –* Blood sampling for nutrition and inflammatory status * Stool sampling before indicated gastroscopy and colonoscopy * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma |
| Liver transplantation recipient (LTX) | – | –* Blood sampling for nutrition and inflammatory status * Stool sampling before indicated gastroscopy and colonoscopy for evaluation of liver transplantation (LTX) * Questionnaires about general health, gastrointestinal symptoms and 3-day food record * Collection of biopsies in duodenum during gastroscopy * Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy controls patients with inflammatory bowel disease patients with liver disease (liver cirrhoses) and indication for LTX-evaluation
Key inclusion criteria (3 listed)
- healthy volunteers with indication for cancer screening without gastrointestinal symptoms
- patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- patients with indication for evaluation of liver transplantation (LTX)
Key exclusion criteria (2 listed)
- other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors
- antibiotic treatment within 6 weeks before gastroscopy / colonoscopy
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
bacterial composition
Time frame: 1 day
detection of bacterial families in stool and mucosa samples
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 21 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Human Microbiome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 inclusion and 2 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 21 Feb 2022. 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 Germany. 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?
bacterial composition (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 21 Feb 2022.