To explore the effect of 5 weeks daily consumption of Lactobacillus LB product, compared to a placebo supplement, on fecal microbiota composition and diversity in healthy individuals.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
healthy gut physiology/microbiome
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in fecal microbiota composition and fecal microbiota diversity as
assessed by 16S rDNA Illumina (MiSeq) sequencing.
Secondary outcome
Change in plasma CRP concentration in fasting blood samples
Background summary
This research project aims to characterize the effects of Lactobacillus LB
product (a lyophilized, heat-killed Lactobacillus LB with its spent culture
supernatant) on gut bacterial composition in healthy subjects, to find
additional explanations how Lactobacillus LB product may be effective in
treating several gastrointestinal infectious diseases.
Study objective
To explore the effect of 5 weeks daily consumption of Lactobacillus LB product,
compared to a placebo supplement, on fecal microbiota composition and diversity
in healthy individuals.
Study design
Randomised, double-blind, placebo-controlled cross-over trial. After a 1-week
run-in period, subjects will be randomised and assigned to a treatment order.
Treatment periods have a duration of 5 weeks, with a wash-out period of 2 weeks
in between.
Intervention
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 Lactobacillus LB product
(containing 10 billion heat-killed bacteria bodies (kbb)) or sucrose.
Study burden and risks
For this study healthy volunteers are selected. There is no direct benefit from
participation and volunteers will be reimbursed for their time investment. In
total the subjects will visit the clinical facilities 5 times. There are no
known risks associated with the consumption of the IP or placebo. Blood samples
will be taken 4 times during the study and 4 times a spot fecal sample has to
be collected at home by the subject. The risk and burden associated with
participation in this study is considered minimal.
Kernhemseweg 2
Ede 6718ZB
NL
Kernhemseweg 2
Ede 6718ZB
NL
Listed location countries
Age
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
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
Design
Recruitment
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 | NL68859.072.19 |