SwissGut - A Longitudinal Cohort Study of the Healthy Human Faecal Microbiome in Switzerland

Status: Recruiting
Location: See location...
Study Type: Observational
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. 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Switzerland
Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland
RECRUITING
Bern
Contact Information
Primary
Sebastian B. U. Jordi
research.2omrx@passfwd.com
+41 31 664 33 63
Backup
Benjamin Misselwitz, MD
benjamin.misselwitz@insel.ch
+41 31 664 04 30
Time Frame
Start Date: 2023-05-28
Estimated Completion Date: 2025-07-05
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Benjamin Misselwitz

This content was sourced from clinicaltrials.gov