HealthyROBINNCT03114839
Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN)
A study testing Lactobacillus casei strain Shirota (LcS) in people with Healthy, run by Yakult Honsha European Research Center, ESV at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus casei strain Shirota (LcS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Sep 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Use of laxatives and probiotic, prebiotic and fiber supplements during the two (2) months prior to study start.
- Personnel of research institute(s) involved in execution of the study, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to have an X-ray if the capsule is not recovered from the feces.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
NIZO Food Research
Ede, Utrecht,, 6718 ZB
Sandra ten Bruggencate, PhD, +31318659504, sandra.tenbruggencate@nizo.com
Sandra ten Bruggencate, PhD
About this study
Official title: 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®).
Read the 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.
- Conditions
- Healthy
- Being tested
- Lactobacillus casei strain Shirota (LcS)
- Keywords
- Lactobacillus casei strain Shirota, Yakult, IntelliCap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei strain Shirota (LcS)Dietary supplement
Also called Commercial name: Yakult®
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Lactobacillus casei strain Shirota (LcS) | Experimental | Not described Receives: Dietary Supplement: Lactobacillus casei strain Shirota (LcS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition in the small intestine
Relative abundance of microbiota species (% of total) in the small intestine
Measured: 7 days after consuming a probiotic drink containing Lactobacillus casei strain Shirota (LcS)
Secondary outcomes (3)
Microbiota composition in feces
Relative abundance of microbiota species (% of total ) in feces
Measured: 7 days after consuming a probiotic drink containing LcS
LcS recovery
LcS recovery in the small intestine and feces
Measured: 7 days after consuming a probiotic drink containing LcS
Stool habits
Effect of LcS on stool frequency, stool consistency and gastrointestinal symptoms
Measured: 7 days after consuming a probiotic drink containing LcS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start4 Sep 2017 (estimated)
- Primary completion31 Oct 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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 Lactobacillus casei strain Shirota.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yakult Honsha European Research Center, ESV
- Sponsor type
- University, hospital or other
- Collaborators
- NIZO Food Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114839
- Sponsor's protocol ID
- NL59320.081.16
- Acronym
- ROBIN
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03114839
- Acronym / sponsor ID
- ROBIN / NL59320.081.16
- Conditions
- Healthy
- Keywords
- Lactobacillus casei strain Shirota, Yakult, IntelliCap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Yakult Honsha European Research Center, ESVUniversity, hospital or other
- Collaborators
- NIZO Food Research
- Study start
- 4 Sep 2017 (estimated)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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 Lactobacillus casei strain Shirota.
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Lactobacillus casei strain Shirota (LcS) | Experimental | Dietary Supplement: Lactobacillus casei strain Shirota (LcS) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus casei strain Shirota (LcS)Also: Commercial name: Yakult®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. | Dietary supplement | Dietary Supplement: Lactobacillus casei strain Shirota (LcS) |
Primary outcome
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
3 secondary outcomes
Microbiota composition in feces
Time frame: 7 days after consuming a probiotic drink containing LcS
LcS recovery
Time frame: 7 days after consuming a probiotic drink containing LcS
Stool habits
Time frame: 7 days after consuming a probiotic drink containing LcS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei strain Shirota (LcS) in people with Healthy, run by Yakult Honsha European Research Center, ESV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra ten Bruggencate, PhD (+31318659504, sandra.tenbruggencate@nizo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition in the small intestine (time frame: 7 days after consuming a probiotic drink containing Lactobacillus casei strain Shirota (LcS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.