To support the validity of an in vitro colonic fermentation system, by demonstrating that changes in gut microbiota composition and functionality/metabolism, induced by prebiotics in the in vitro Microcolon model, are mimicking the changes that are…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
small and large intestinal microbiome in healthy subjects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in gut microbiota composition (comparison between in vitro MicroColon
model and in vivo human results). Composition changes of interest will include
Bifidobacterium (genus), Bifidobacterium species, Lactobacillaceae (family),
Parabacteroides distasonis , Anaerobutyricum hallii and Faecalibacterium
prausnitzii.
Secondary outcome
More general changes in microbiota composition, diversity and functionality
(comparison between in vitro MicroColon model and in vivo human results).
Explorative outcomes include the practical application (logistics, feasibility,
acceptability) of a small intestinal sampling capsule in vivo and the
comparison of small intestinal microbiome with fecal microbiome, at the
individual level.
Background summary
At NIZO, the so-called MicroColon model has been developed over the last
decade. This miniaturized fermentation model is used to evaluate the
interaction of the gut microbiome (from fresh human fecal samples) with food
ingredients. However, results of interventions in this in vitro model have not
yet been directly compared with the same interventions in vivo.
Therefore we propose to perform a study in healthy human volunteers, in which
the short-term in vitro effects of specific ingredients on the gut microbiota
composition and functionality in the MicroColon will be compared with the
effects of consumption of these same ingredients on gut microbiota composition
and functionality in a human study.
Study objective
To support the validity of an in vitro colonic fermentation system, by
demonstrating that changes in gut microbiota composition and
functionality/metabolism, induced by prebiotics in the in vitro Microcolon
model, are mimicking the changes that are observed in a human intervention
setting. Secondary objective is to test the application of a small intestinal
sampling capsule in vivo.
Study design
The study is designed as an open-label intervention with before-after
comparison, with the aim to compare in vivo with in vitro outcomes.
Intervention
Resistant dextrin and 2*-FL (a human milk oligosaccharide) will each be
consumed daily in a dose of 10 g by 5 healthy adult volunteers, for a period of
3 weeks.
Study burden and risks
Participants will collect a fecal sample at 2 time points, and they will
consume a commercially available dietary fibre supplement for 3 weeks. They
will also swallow two sampling capsules, which they will retrieve from their
feces. Burden and risks associated with participation are considered small.
Kernhemseweg 2
Ede 6718ZB
NL
Kernhemseweg 2
Ede 6718ZB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86394.028.24 |