small and large intestinal microbiome in healthy subjects shift in gut microbiome
Conditions
Interventions
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.
Sponsors
NIZO food research B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 y 2. Healthy as assessed by general health questionnaire 3. BMI >=18.5 and
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed