Comparing food-induced gut microbiome shifts in vitro and in vivo

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Age >= 18 y
2. Healthy as assessed by general health questionnaire
3. BMI >=18.5 and <=30
4. Regular bowel habits, defined as at least once per 2 days
5. Adherence to habitual diet and lifestyle, no changes during study period
6. Signed informed consent

Exclusion Criteria

1. Lower gastrointestinal conditions, such as diarrhea/loose stools or acute
gastrointestinal infection in the month before fecal donation, constipation, IBS
2. Diagnosed gastrointestinal disorders (for example, but not limited to,
ulcers, IBD, achalasia, eosinophilic esophagitis, hiatus hernia,
gastrointestinal cancer diagnosis or treatment within the past year), or
previous esophageal, gastric, small intestinal, or colonic surgery;
appendectomy or cholecystectomy more than 3 months prior to on-site study visit
are acceptable
3. Use of prebiotics or probiotics (an indicative list will be provided) within
4 weeks before fecal donation
4. Use of oral/IV antibiotics in 6 months before fecal donation
5. Fecal Microbiota Transplantation anytime in medical history
6. Use of laxatives within 2 weeks before fecal donation
7. Any clinically significant systemic infection at time of screening
8. Use of medication (for example, but not limited to, opioids, prokinetics,
anticholinergics, proton pump inhibitors (PPI)) or dietary supplements that
could affect bowel movement / gut motility, or with a history of systemic
disease that might affect gut motility according to the investigator; or which
could otherwise impact the results of the study
9. History of oropharyngeal dysphagia, or other swallowing disorder with a risk
of capsule as-piration
10. History of abdominal radiation treatment
11. Major genital and/or rectum prolapse at the time of screening or other
physical abnormali-ties that may impair capsule excretion according to the
investigator
12. Alcohol consumption >= 3 units/day
13. Participation in any clinical trial including blood sampling and/or
administration of substances starting 1 month prior to study start and during
the entire study
14. Pregnancy
15. Not expected to be able to comply with study procedure including SIMBA
capsule recovery with - or without help, according to the investigator
16. NIZO employee or first degree relative

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in gut microbiota composition (comparison between in vitro MicroColon<br /><br>model and in vivo human results). Composition changes of interest will include<br /><br>Bifidobacterium (genus), Bifidobacterium species, Lactobacillaceae (family),<br /><br>Parabacteroides distasonis , Anaerobutyricum hallii and Faecalibacterium<br /><br>prausnitzii.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>More general changes in microbiota composition, diversity and functionality<br /><br>(comparison between in vitro MicroColon model and in vivo human results).<br /><br><br /><br>Explorative outcomes include the practical application (logistics, feasibility,<br /><br>acceptability) of a small intestinal sampling capsule in vivo and the<br /><br>comparison of small intestinal microbiome with fecal microbiome, at the<br /><br>individual level.</p><br>