Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) (ROBIN)

June 26, 2017 updated by: Yakult Honsha European Research Center, ESV

The Effect of Daily Consumption of a Probiotic Drink Containing Lactobacillus Casei Strain Shirota on the Small Intestinal Microbiota in Healthy Male Subjects as Measured by the IntelliCap Sampling Capsule System.

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®).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Ede, Utrecht,, Netherlands, 6718 ZB
        • Recruiting
        • NIZO food research
        • Contact:
        • Principal Investigator:
          • Sandra ten Bruggencate, PhD
        • Sub-Investigator:
          • Esther Floris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male
  2. Age 18-30yrs
  3. BMI between 18,5-25 kg/m2
  4. Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid").
  5. Non-smoking
  6. Regular bowel movement (defecation on average once a day, at least 4 times/week).
  7. Signed informed consent
  8. Access to internet
  9. Access to freezer for storage of biological samples
  10. Voluntary participation
  11. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned.
  12. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for the study for at least 15 years.
  13. Willing to accept information-transfer concerning participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
  14. Willing to comply with study procedures.

Exclusion Criteria:

  1. Alcohol consumption > 15 units/week and > 3/day.
  2. Allergic to dairy products (milk allergy or lactose intolerance).
  3. Carrying a pacemaker or any other (implanted) medical electronic device.
  4. Drug abuse.
  5. Having diarrhea within two (2) months prior to the study start.
  6. Heavy exercise or sports training > 10 hours/week.
  7. History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  8. Mental status that is incompatible with the proper conduct of the study.
  9. Participation in any scientific study with oral, intravenous or inhalatory administration of any substances during two (2) months before study start.
  10. Presence of swallowing disorder or problems with gastro-intestinal transit.
  11. Reported special diets such as vegetarian, vegan, or macrobiotic.
  12. Scheduled for an MRI scan during the study period.
  13. Unstable body weight (weight gain or loss >5kg in the past three (3) months).
  14. Use of antibiotics during the six (6) months prior to study start.
  15. Use of any prescribed or non-prescribed medication (other than paracetamol) during the three (3) weeks prior to study start.
  16. Use of laxatives and probiotic, prebiotic and fiber supplements during the two (2) months prior to study start.
  17. Personnel of research institute(s) involved in execution of the study, their partner and their first and second degree relatives
  18. Not having a general practitioner
  19. Not willing to have an X-ray if the capsule is not recovered from the feces.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dietary Supplement: Lactobacillus casei strain Shirota (LcS)
Dietary supplement: Lactobacillus casei strain Shirota (LcS)
A fermented milk containing LcS, 65 ml for oral administration, 1 bottle per day for 7 days. One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10^9 colony-forming units of LcS.
Other Names:
  • Commercial name: Yakult®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiota composition in the small intestine
Time Frame: 7 days after consuming a probiotic drink containing Lactobacillus casei strain Shirota (LcS)
Relative abundance of microbiota species (% of total) in the small intestine
7 days after consuming a probiotic drink containing Lactobacillus casei strain Shirota (LcS)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiota composition in feces
Time Frame: 7 days after consuming a probiotic drink containing LcS
Relative abundance of microbiota species (% of total ) in feces
7 days after consuming a probiotic drink containing LcS
LcS recovery
Time Frame: 7 days after consuming a probiotic drink containing LcS
LcS recovery in the small intestine and feces
7 days after consuming a probiotic drink containing LcS
Stool habits
Time Frame: 7 days after consuming a probiotic drink containing LcS
Effect of LcS on stool frequency, stool consistency and gastrointestinal symptoms
7 days after consuming a probiotic drink containing LcS

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: 7 days after consuming a probiotic drink containing LcS
Feasibility assessment of measuring potential biomarkers in the small intestine and feces
7 days after consuming a probiotic drink containing LcS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yakult Honsha European Research Center, ESV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NIZO Food Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL59320.081.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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