Study of the effect of Lactobacillus LB product on healthy volunteers' fecal microbiota compositio
- Conditions
- healthy gut physiology/microbiomeintestinal floraMicrobiota
- Registration Number
- NL-OMON48365
- Lead Sponsor
- IZO food research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
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 <1 per 2 days.
6. 6. Having used Lactobacillus LB product/s or (products containing) added pro- and/or prebiotics within 2 weeks prior to inclusion.
7. Use of antibiotics or regular use of norit or laxatives (in 6 months prior to inclusion)
8. Reported special diets such as vegetarian, vegan, or macrobiotic.
9. A self-reported lactose intolerance.
10. Pregnancy or lactating;Procedural:
11. Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results.
12. 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.
13. Personnel of NIZO food research and Adare Pharmaceuticals and their partner and their first and second degree relatives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in fecal microbiota composition and fecal microbiota diversity as<br /><br>assessed by 16S rDNA Illumina (MiSeq) sequencing.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in plasma CRP concentration in fasting blood samples</p><br>