healthy gut physiology/microbiome intestinal flora Microbiota
Conditions
Interventions
Lactobacillus LB product and placebo will be provided to the subjects as
capsules. Subjects will receive 4 capsules per day divided into two servings
(2x2) for 5 weeks. Capsules contain 170 mg of La
Sponsors
NIZO food research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;Substantial 1. Age *18 and *65 years. 2. BMI *18.5 and *30.0 kg/m2. 3. Healthy as assessed by the NIZO health questionnaire.;Procedural: 4. Ability to follow Dutch verbal and written instructions. 5. Availability of internet connection. 6. Signed informed consent. 7. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned. 8. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years. 9. Willing to comply with study procedures and guidelines, including collection of stool and blood samples. 10. Willingness to abstain from (products containing) probiotics and prebiotics starting from run-in and during the entire study. 11. Willingness to give up blood donation starting at run-in and during the entire study. 12. Willing to take precautions not to become pregnant during the study period. 13. Willingness to avoid use of dietary fiber supplements along the duration of the study
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;Substantial: 1. Acute gastroenteritis in the 2 months prior to inclusion. 2. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, gastrointestinal, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 3. Any active infections, potentially requiring antibiotic use, at time of screening 4. Excessive alcohol usage (men: >4 consumptions/day or >20 consumptions/week; women: >3 consumptions/day or >15 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study. 5. Reported average stool frequency of >3 per day or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fecal microbiota composition and fecal microbiota diversity as assessed by 16S rDNA Illumina (MiSeq) sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma CRP concentration in fasting blood samples | — |
Countries
Netherlands
Outcome results
None listed