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

NCT03114839 | Unknown

• 1 other identifier: NL59320.081.16
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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®).

Conditions

Healthy

Keywords

Lactobacillus casei strain Shirota; Yakult; IntelliCap

Outcome Measures

Primary Outcomes (1)

• Microbiota composition in the small intestine

  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 Outcomes (3)

• Microbiota composition in feces

  7 days after consuming a probiotic drink containing LcS

• LcS recovery

  7 days after consuming a probiotic drink containing LcS

• Stool habits

  7 days after consuming a probiotic drink containing LcS

Other Outcomes (1)

• Biomarkers

  7 days after consuming a probiotic drink containing LcS

Study Arms (1)

Dietary Supplement: Lactobacillus casei strain Shirota (LcS)

EXPERIMENTAL

Dietary Supplement: Lactobacillus casei strain Shirota (LcS)

Interventions

Lactobacillus casei strain Shirota (LcS) DIETARY_SUPPLEMENT

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.

Also known as: Commercial name: Yakult®

Dietary Supplement: Lactobacillus casei strain Shirota (LcS)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age 18-30yrs
• BMI between 18,5-25 kg/m2
• Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid").
• Non-smoking
• Regular bowel movement (defecation on average once a day, at least 4 times/week).
• Signed informed consent
• Access to internet
• Access to freezer for storage of biological samples
• Voluntary participation
• Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned.
• 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.
• 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.
• Willing to comply with study procedures.

You may not qualify if:

• Alcohol consumption \> 15 units/week and \> 3/day.
• Allergic to dairy products (milk allergy or lactose intolerance).
• Carrying a pacemaker or any other (implanted) medical electronic device.
• Drug abuse.
• Having diarrhea within two (2) months prior to the study start.
• Heavy exercise or sports training \> 10 hours/week.
• 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.
• Mental status that is incompatible with the proper conduct of the study.
• Participation in any scientific study with oral, intravenous or inhalatory administration of any substances during two (2) months before study start.
• Presence of swallowing disorder or problems with gastro-intestinal transit.
• Reported special diets such as vegetarian, vegan, or macrobiotic.
• Scheduled for an MRI scan during the study period.
• Unstable body weight (weight gain or loss \>5kg in the past three (3) months).
• Use of antibiotics during the six (6) months prior to study start.
• Use of any prescribed or non-prescribed medication (other than paracetamol) during the three (3) weeks prior to study start.

Sponsors & Collaborators

• Yakult Honsha European Research Center, ESV: lead
• NIZO Food Research: collaborator

Study Sites (1)

NIZO Food Research

Ede, Utrecht,, 6718 ZB, Netherlands

RECRUITING

Central Study Contacts

Sandra ten Bruggencate, PhD

CONTACT

+31318659504; sandra.tenbruggencate@nizo.com

Els Van Hoffen, PhD

CONTACT

+31318659560; els.vanhoffen@nizo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Lactobacillus casei strain Shirota.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 14, 2017
• Study Start: September 4, 2017
• Primary Completion: October 31, 2017
• Study Completion: February 28, 2018
• Last Updated: June 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)