The effects of oral administration of lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on small intestinal mucosa and barrier function

The intestine harbours large amounts of bacteria which are essential for the
proper functioning of the digestive system. They are among others involved in
the degradation of nutrients and the body's immune system. Little is known
about the exact health benefits of providing additional 'good ' bacteria in the
small intestine. This is mainly due to the small intestine are difficult to
study, by its poorly accessible position in the body.
In this study we will examine effects of three food bacteria.

This research aims to investigate the effects of three bacteria in the small
intestine. This study will provide detailed information on all processes in the
small intestine. By the used analytical technique, including gene expression
technology, not only information about 'likely' processes is obtained, but
also about all other processes. Furthermore, information of putative probiotics
on functional parameters of gut health is obtained.

The study consists of four different periods. During each period, the effects
of one of the three bacteria or placebo, an inactive substance, will be
investigated. Each participant will go through all four time periods according
to the randomized double-blind placebo-controlled cross-over design of this
study.
Before starting a test period, a sugar test that provides insights into the
barrier function of the intestine will be performed.Two days later, this test
is repeated, with concomitant administration of indomethacin. These
permeability assessments serve to obtain baseline values of intestinal
permeability.
The day after this second sugar test, the participant begins to take the
bacteria. The bacteria are provided in small jars. They're in a dry form in
those jars. He / she also gets a jar of sugar. Fifteen minutes before
consumption, the jar needs to be filled with water, as shown and instructed
during the first visit to the investigator. Then drink the 'probiotic' drinks
within one minute. The supplements will need to be taken during breakfast and
dinner for a 7-days period. After this 7-day period, Intestinal permeability
will be assessed again with the 'indomethacin' protocol. If he / she appears as
agreed at the hospital, a sugar test will first be carried out, followed by a
bowel examination. During this procedure, samples from the duodenal mucosa are
obtained by standard flexible gastroduodenoscopy.
Before and after each test week, a blood sample will be collected. Also,
subjects will have to fill in a questionnaires which relates to bowel habits.
Another bowel symptom questionnaire will have to be completed on the evening of
each day.

There will be a wash-out period of 4 weeks in between two experiments.

Food supplements (probiotics) for 4 periods of 1 week each, sugar tests with
subsequent urine collection, gastroduodenoscopy (intestinal investigation)

Bruise by blood sampling
The chance of complications during gastroduodenoscopy, such as a mild bleeding
at the site of the biopsy, is about 0.13%, including a 0.03% chance of
perforation.