SwissGut - The Healthy Swiss Microbiome — SwissGut  

Healthy Clinical Trial

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

Status Recruiting

Clinical 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.

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT06191224
• Study type: Observational
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Sebastian B. U. Jordi
• Phone: +41 31 664 33 63
• Email: research.2omrx@passfwd.com
• Status: Recruiting
• Start date: May 28, 2023
• Completion date: July 5, 2025