HealthySwissGutNCT06191224
SwissGut - The Healthy Swiss Microbiome
An observational study of Healthy, run by Benjamin Misselwitz at 1 site in Switzerland.
Trial summary
Objective: This study is designed to address the complex interplay between the gut microbiome, environmental factors, and inflammatory diseases, with a specific emphasis on serving as a healthy cohort for several related projects. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 May 2023to 5 Jul 2025
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be recruited through convenience sampling at our institution in Bern and via outreach to the general population Switzerland-wide with a bias favouring the German speaking parts because documents are in German only. No members of the study team will be participants.
Who may be able to join
- Signed informed consent
- Age 18-90 years
- General ability to give consent for study inclusion, understand and follow study procedures
- No current or past diagnosis of IBD or colorectal carcinoma
- No current medical complaints typical for IBD or other severe intestinal diseases (e.g. Diarrhea, severe constipation, abdominal pain, blood in stool, weight loss). Minor symptoms, (not impairing daily activities) are permitted.
- No other current relevant gastrointestinal disease or condition plausibly interfering with microbiota assessment according to the discretion of the study physician.
Who cannot join
- All patients with recent acute gastrointestinal disease (e.g., confirmed infectious diarrhea) within the last month or relevant intestinal symptoms (impairing daily activities).
- Use of antibiotics within the last 3 months.
- Current pouch or ileostomy/ colostomy.
- Severe medical, surgical, or psychiatric comorbidities interfering with study procedure according to the judgement of the investigator (patients with comorbidities that would not interfere with the primary endpoints I-III but don't allow the assessment of HRV according to the judgement of the investigator (e.g. heart diseases) will be included in the study but the HRV will not be assessed).
- Participation in an interfering clinical study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
Bern, 3010
Benjamin Misselwitz, MD, +41 31 664 04 30, benjamin.misselwitz@insel.ch
Sebastian B. U. Jordi
About this study
Official title: SwissGut - A Longitudinal Cohort Study of the Healthy Human Faecal Microbiome in Switzerland
Objective:
This study is designed to address the complex interplay between the gut microbiome, environmental factors, and inflammatory diseases, with a specific emphasis on serving as a healthy cohort for several related projects.
Read more
Primary hypotheses:
Since data from this study will be used as control data for four studies, four primary hypothesis will be defined.
Hypothesis H1: Levels of intestinal inflammation will be substantially higher in Zimbabweans living in rural areas and low-resource settings (i.e. high-density areas) compared to Zimbabwean and Swiss individuals living in high-resource settings.
Hypothesis H2: Bottlenecks and blooms of bacterial strains are less frequent in healthy participants than in inflammatory bowel disease (IBD) patients and bacterial strains will have lower mutation rates in healthy patients when compared to strains from IBD subjects (partner study: BASEC 2021-00871).
Hypothesis H3: Longitudinal changes of the faecal microbiome of healthy Swiss individuals differ systematically compared to longitudinal changes of the faecal microbiome of Swiss UC patients with active disease (partner study: BASEC 2022-02008).
Hypothesis H4: The HRV of healthy Swiss individuals differ systematically from HRV of Swiss IBD patients and can be associated with differentially abundant bacterial taxa (partner study: BASEC 2022-02008).
Read the detailed description
Objective:
This study investigates the relationship between lifestyle, gut bacteria, and diseases such as colorectal cancer and inflammatory bowel diseases (IBD). The investigators aim to understand how the gut microbiome, influenced by different environments, impacts disease development. Our research focuses on healthy Swiss individuals as a control group for ongoing projects.
Primary hypotheses:
Since data from this study will be used as control data for four studies, four primary hypothesis will be defined.
Hypothesis H1: Levels of intestinal inflammation will be substantially higher in Zimbabweans living in rural areas and low-resource settings (i.e. high-density areas) compared to Zimbabwean and Swiss individuals living in high-resource settings.
Hypothesis H2: Bottlenecks and blooms of bacterial strains are less frequent in healthy participants than in IBD patients and bacterial strains will have lower mutation rates in healthy patients when compared to IBD subjects (partner study: BASEC 2021-00871).
Hypothesis H3: Longitudinal changes of the faecal microbiome of healthy Swiss individuals differ systematically compared to longitudinal changes of the faecal microbiome of Swiss UC patients with active disease (partner study: BASEC 2022-02008).
Hypothesis H4: The heart rate variability (HRV) of healthy Swiss individuals differ systematically from HRV of Swiss IBD patients and can be associated with differentially abundant bacterial taxa (partner study: BASEC 2022-02008).
Secondary hypotheses Hypothesis H5: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome composition of healthy Zimbabweans. (O1)
Hypothesis H6: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome of Swiss UC patients experiencing a disease flare.
Hypothesis H7: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome of Swiss UC patients after achieving disease remission.
Hypothesis H8: The faecal microbiome composition of healthy Swiss without symptoms of irritable bowel syndrome (Rome IV criteria) differs systematically from the faecal microbiome of healthy Swiss with symptoms of irritable bowel syndrome.
Design:
Observational cohort study with 200 healthy Swiss participants. Participants are followed-up during one year. During the study, 12 faecal samples, voluntary blood samples, and comprehensive data are collected from each participant. Assessed data include clinical assessments, detailed socio-economic information and voluntary heart rate variability (HRV) measurements. The study's longitudinal approach comprises 12 defined follow-ups at days 0, 3, 5, and 7; weeks 2, 3, 4, 8, and 12; and months 6, 9, and 12. The faecal samples will be collected by the participants at home with provided vials. In addition, each faecal sample is accompanied by a follow-up questionnaire to filled out by the patient. The questionnaires focus on gastrointestinal symptoms, fatigue, socio-economic variables, emotional well-being, five factor model (personality) assessment and type D personality, and a simple dietary assessment covering a 24-hour period. Participants will mail the stool vials and questionnaires, using a provided envelope, to Inselspital Bern via the Swiss postal service. Blood samples will be acquired only from a subset of the participants primarily at enrolment.
Recruitment:
Primarily at the Department of Visceral Surgery and Medicine of the University Hospital Bern (Inselspital Bern), and through outreach to the general population.
- Conditions
- Healthy
- Keywords
- microbiota, microbiome, health, hygiene, lifestyle, mental health, personality, inflammatory bowel disease, irritable bowel disease, nutrition
- Medical subject headings
- Psychological Well-Being, Inflammatory Bowel Diseases, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal inflammation - healthy Swiss vs. healthy Zimbabweans
Difference in calprotectin levels of healthy Swiss individuals and healthy Zimbabweans in high-resource settings compared to calprotectin levels in Zimbabweans in low-resource settings.
Measured: All sampling timepoints will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Evolutionary dynamics of bacterial strains - Swiss healthy vs. Swiss IBD
The evolutionary dynamics of the most frequent and the most abundant bacteria in healthy Swiss individuals compared to Swiss IBD patients by assessing mutation rate per genome per generation.
Comment: calculation of mutation rates is only feasible for abundant bacteria which can be found in a high fraction of participants over more than one timepoint. The investigators will thus determine the most suitable bacterial species and focus the analysis on this bacterial species.
Measured: All timepoints with samples in both groups will be analysed.
Intra-individual microbiome composition changes - Swiss healthy vs. Swiss UC with initial active disease
Difference in absolute dissimilarity (weighted Unifrac index) changes within individuals over time between the faecal microbiomes of healthy Swiss individuals and the faecal microbiomes of Swiss UC patients initially experiencing a disease flare.
Measured: Samples from enrolment and after 12 months will be analysed. Alternatively, samples from enrolment and a second timepoint (> 1 week later) with the most available samples and relevant metadata will be prioritised.
Heart rate variability - Swiss healthy vs. Swiss IBD
Heart rate variability (the root mean square of successive differences) measurements compared between healthy Swiss individuals and Swiss IBD patients.
Measured: Measurments from the first timepoint with heart rate variability assessment will be analysed.
Secondary outcomes (5)
Difference in healthy microbiome composition - Swiss vs. Zimbabweans
Dissimilarity (weighted Unifrac index) between the microbiomes of healthy Swiss individuals and the microbiomes of healthy Zimbabweans. (H5) The endpoint will be tested by performing a permutational multivariate analysis of variance of the index with the adonis function of the vegan R package or another appropriate method.
Measured: All sampling timepoints will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy vs. Swiss UC active
Dissimilarity (weighted Unifrac index) between the microbiomes of healthy Swiss individuals and the microbiomes of Swiss UC patients with active disease (i.e., in a disease flare). (H6) The endpoint will be tested by performing a permutational multivariate analysis of variance of the index with the adonis function of the vegan R package or another appropriate method.
Measured: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy vs. Swiss UC remission
Dissimilarity (weighted Unifrac index) between the microbiomes of healthy Swiss individuals and the microbiomes of Swiss UC patients with inactive disease (i.e., remission). (H7) The endpoint will be tested by performing a permutational multivariate analysis of variance of the index with the adonis function of the vegan R package or another appropriate method.
Measured: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy no IBS vs. Swiss healthy IBS
Dissimilarity (weighted Unifrac index) between the microbiomes of healthy Swiss with and without symptoms of irritable bowel syndrome (Rome IV criteria). (H8) The endpoint will be tested by performing a permutational multivariate analysis of variance of the index with the adonis function of the vegan R package or another appropriate method.
Measured: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss low HRV vs. Swiss high HRV
Dissimilarity (weighted Unifrac index) between the microbiomes of individuals with a low heart rate variability compared to individuals with a high HRV. (H8) The endpoint will be tested by performing a permutational multivariate analysis of variance of the index with the adonis function of the vegan R package or another appropriate method.
Measured: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 May 2023
- Primary completion5 Jul 2025 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin Misselwitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Misselwitz, Insel Gruppe AG, University Hospital Bern
- Investigators
- Benjamin Misselwitz, MD, Principal investigator, Inselspital, Bern University HospitalSebastian B. U. Jordi, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191224
- Sponsor's protocol ID
- BASEC 2023-00706
- Acronym
- SwissGut
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A majority of participants are expected to provide consent for the continued use of their data and samples. These samples and data may be shared in collaborative efforts with other researchers upon reasonable request and subsequent review by the Principal Investigator (PI) and Study Director. The decision regarding sharing is always at the discretion of the PI and Study Director and does not need to be justified.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SwissGut - A Longitudinal Cohort Study of the Healthy Human Faecal Microbiome in Switzerland
- ClinicalTrials.gov ID
- NCT06191224
- Acronym / sponsor ID
- SwissGut / BASEC 2023-00706
- Conditions
- Healthy
- Keywords
- microbiota, microbiome, health, hygiene, lifestyle, mental health, personality, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benjamin MisselwitzUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
Objective:
This study is designed to address the complex interplay between the gut microbiome, environmental factors, and inflammatory diseases, with a specific emphasis on serving as a healthy cohort for several related projects.
Primary hypotheses:
Since data from this study will be used as control data for four studies, four primary hypothesis will be defined.
Hypothesis H1: Levels of intestinal inflammation will be substantially higher in Zimbabweans living in rural areas and low-resource settings (i.e. high-density areas) compared to Zimbabwean and Swiss individuals living in high-resource settings.
Hypothesis H2: Bottlenecks and blooms of bacterial strains are less frequent in healthy participants than in inflammatory bowel disease (IBD) patients and bacterial strains will have lower mutation rates in healthy patients when compared to strains from IBD subjects (partner study: BASEC 2021-00871).
Hypothesis H3: Longitudinal changes of the faecal microbiome of healthy Swiss individuals differ systematically compared to longitudinal changes of the faecal microbiome of Swiss UC patients with active disease (partner study: BASEC 2022-02008).
Hypothesis H4: The HRV of healthy Swiss individuals differ systematically from HRV of Swiss IBD patients and can be associated with differentially abundant bacterial taxa (partner study: BASEC 2022-02008).
Detailed description
Objective:
This study investigates the relationship between lifestyle, gut bacteria, and diseases such as colorectal cancer and inflammatory bowel diseases (IBD). The investigators aim to understand how the gut microbiome, influenced by different environments, impacts disease development. Our research focuses on healthy Swiss individuals as a control group for ongoing projects.
Primary hypotheses:
Since data from this study will be used as control data for four studies, four primary hypothesis will be defined.
Hypothesis H1: Levels of intestinal inflammation will be substantially higher in Zimbabweans living in rural areas and low-resource settings (i.e. high-density areas) compared to Zimbabwean and Swiss individuals living in high-resource settings.
Hypothesis H2: Bottlenecks and blooms of bacterial strains are less frequent in healthy participants than in IBD patients and bacterial strains will have lower mutation rates in healthy patients when compared to IBD subjects (partner study: BASEC 2021-00871).
Hypothesis H3: Longitudinal changes of the faecal microbiome of healthy Swiss individuals differ systematically compared to longitudinal changes of the faecal microbiome of Swiss UC patients with active disease (partner study: BASEC 2022-02008).
Hypothesis H4: The heart rate variability (HRV) of healthy Swiss individuals differ systematically from HRV of Swiss IBD patients and can be associated with differentially abundant bacterial taxa (partner study: BASEC 2022-02008).
Secondary hypotheses Hypothesis H5: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome composition of healthy Zimbabweans. (O1)
Hypothesis H6: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome of Swiss UC patients experiencing a disease flare.
Hypothesis H7: The faecal microbiome composition of healthy Swiss individuals differs systematically from the faecal microbiome of Swiss UC patients after achieving disease remission.
Hypothesis H8: The faecal microbiome composition of healthy Swiss without symptoms of irritable bowel syndrome (Rome IV criteria) differs systematically from the faecal microbiome of healthy Swiss with symptoms of irritable bowel syndrome.
Design:
Observational cohort study with 200 healthy Swiss participants. Participants are followed-up during one year. During the study, 12 faecal samples, voluntary blood samples, and comprehensive data are collected from each participant. Assessed data include clinical assessments, detailed socio-economic information and voluntary heart rate variability (HRV) measurements. The study's longitudinal approach comprises 12 defined follow-ups at days 0, 3, 5, and 7; weeks 2, 3, 4, 8, and 12; and months 6, 9, and 12. The faecal samples will be collected by the participants at home with provided vials. In addition, each faecal sample is accompanied by a follow-up questionnaire to filled out by the patient. The questionnaires focus on gastrointestinal symptoms, fatigue, socio-economic variables, emotional well-being, five factor model (personality) assessment and type D personality, and a simple dietary assessment covering a 24-hour period. Participants will mail the stool vials and questionnaires, using a provided envelope, to Inselspital Bern via the Swiss postal service. Blood samples will be acquired only from a subset of the participants primarily at enrolment.
Recruitment:
Primarily at the Department of Visceral Surgery and Medicine of the University Hospital Bern (Inselspital Bern), and through outreach to the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited through convenience sampling at our institution in Bern and via outreach to the general population Switzerland-wide with a bias favouring the German speaking parts because documents are in German only. No members of the study team will be participants.
Key inclusion criteria (6 listed)
- Signed informed consent
- Age 18-90 years
- General ability to give consent for study inclusion, understand and follow study procedures
- No current or past diagnosis of IBD or colorectal carcinoma
- No current medical complaints typical for IBD or other severe intestinal diseases (e.g. Diarrhea, severe constipation, abdominal pain, blood in stool, weight loss). Minor symptoms, (not impairing daily activities) are permitted.
Key exclusion criteria (5 listed)
- All patients with recent acute gastrointestinal disease (e.g., confirmed infectious diarrhea) within the last month or relevant intestinal symptoms (impairing daily activities).
- Use of antibiotics within the last 3 months.
- Current pouch or ileostomy/ colostomy.
- Severe medical, surgical, or psychiatric comorbidities interfering with study procedure according to the judgement of the investigator (patients with comorbidities that would not interfere with the primary endpoints I-III but don't allow the assessment of HRV according to the judgement of the investigator (e.g. heart diseases) will be included in the study but the HRV will not be assessed).
- Participation in an interfering clinical study.
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
Intestinal inflammation - healthy Swiss vs. healthy Zimbabweans
Time frame: All sampling timepoints will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in calprotectin levels of healthy Swiss individuals and healthy Zimbabweans in high-resource settings compared to calprotectin levels in Zimbabweans in low-resource settings.
Evolutionary dynamics of bacterial strains - Swiss healthy vs. Swiss IBD
Time frame: All timepoints with samples in both groups will be analysed.
The evolutionary dynamics of the most frequent and the most abundant bacteria in healthy Swiss individuals compared to Swiss IBD patients by assessing mutation rate per genome per generation. Comment: calculation of mutation rates is only feasible for abundant bacteria which can be found in a high fraction of participants over more than one timepoint. The investigators will thus determine the most suitable bacterial species and focus the analysis on this bacterial species.
Intra-individual microbiome composition changes - Swiss healthy vs. Swiss UC with initial active disease
Time frame: Samples from enrolment and after 12 months will be analysed. Alternatively, samples from enrolment and a second timepoint (> 1 week later) with the most available samples and relevant metadata will be prioritised.
Difference in absolute dissimilarity (weighted Unifrac index) changes within individuals over time between the faecal microbiomes of healthy Swiss individuals and the faecal microbiomes of Swiss UC patients initially experiencing a disease flare.
Heart rate variability - Swiss healthy vs. Swiss IBD
Time frame: Measurments from the first timepoint with heart rate variability assessment will be analysed.
Heart rate variability (the root mean square of successive differences) measurements compared between healthy Swiss individuals and Swiss IBD patients.
5 secondary outcomes
Difference in healthy microbiome composition - Swiss vs. Zimbabweans
Time frame: All sampling timepoints will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy vs. Swiss UC active
Time frame: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy vs. Swiss UC remission
Time frame: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss healthy no IBS vs. Swiss healthy IBS
Time frame: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Difference in microbiome composition - Swiss low HRV vs. Swiss high HRV
Time frame: All sampling timepoints of defined subgroups will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided. A majority of participants are expected to provide consent for the continued use of their data and samples. These samples and data may be shared in collaborative efforts with other researchers upon reasonable request and subsequent review by the Principal Investigator (PI) and Study Director. The decision regarding sharing is always at the discretion of the PI and Study Director and does not need to be justified.
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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.
Benjamin Misselwitz, MD principal investigator
Inselspital, Bern University Hospital
Sebastian B. U. Jordi study director
University of Bern
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, run by Benjamin Misselwitz at 1 site in Switzerland.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian B. U. Jordi (+41 31 664 33 63, research.2omrx@passfwd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal inflammation - healthy Swiss vs. healthy Zimbabweans (time frame: All sampling timepoints will be analysed, accounting for dependence between samples from the same individual. Alternatively, the timepoint with the most available samples and relevant metadata will be prioritised.). The study lists 4 primary outcomes in all. 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 23 Jan 2024.