Clinical Trials Logo

Clinical Trial Summary

Currently, obtaining samples directly from the small bowel is difficult due to the highly invasive intubation methods used. Research on the effect of dietary probiotics on the gut microbiota is therefore largely dependent on measurement of the microbial composition in fecal samples. At best, the measurement in fecal samples reflects microbial composition of the large intestine. The microbial composition in the small intestine differs substantially from the composition in feces. In addition, many physiological processes that are modulated by dietary probiotics, such as immunoregulation, mainly occur in the small intestine. Therefore, it is vital to study the effects of dietary probiotics on the small intestinal microbiota, as well. Successful sampling of the small intestine has been demonstrated in animals and humans, using the IntelliCap® CR system. The main aim of the current study is to explore and compare the small intestinal microbiota profiles in healthy subjects before and after consumption of a probiotic drink containing Lactobacillus casei strain Shirota (LcS) (Yakult®).


Clinical Trial Description

The study is a dietary intervention study with a repeated measures design, comparing the upper gastrointestinal microbiota profiles in healthy male subjects before and after consumption of a probiotic drink containing LcS.

This study is explorative in nature. This pilot-study is used to explore trends in microbiota profile shifts in the small intestine. In addition, the investigators would like to explore whether these microbial shifts are similar to those observed in fecal samples. Information derived from this pilot-study can be used to design future intervention studies focusing on either the effect of probiotics on microbial shifts in the small or large intestine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03114839
Study type Interventional
Source Yakult Honsha European Research Center, ESV
Contact Sandra ten Bruggencate, PhD
Phone +31318659504
Email sandra.tenbruggencate@nizo.com
Status Recruiting
Phase N/A
Start date September 4, 2017
Completion date February 28, 2018

See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Active, not recruiting NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Completed NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4
Recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function
Not yet recruiting NCT03617861 - Effect of Secretin in Functional Dyspepsia and Healthy Subjects Phase 1/Phase 2
Completed NCT00091533 - Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects N/A
Completed NCT00068926 - VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases N/A
Completed NCT03280173 - A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood Phase 1