Signs and Symptoms, DigestivePhase 2NCT00822328
Fermented Milk Drink on Human Intestinal Microflora
A Phase 2 study testing Yakult®300 and Lactobacillus casei strain Shirota in people with Signs and Symptoms, Digestive, run by Cheng Hsin Rehabilitation Medical Center at 1 site in Taiwan.
Trial summary
Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Digestive
- What is being tested?
- Yakult®300 and Lactobacillus casei strain Shirota
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers and willing to give voluntary written informed consent
Who cannot join
- Major systemic disease
- Pregnancy, parturient and feeding woman, or expect to be pregnant
- Abnormal liver function
- Abnormal renal function
- Abnormal gastrointestinal function
- Take medication for gastrointestinal function
- Stroke, myocardial infarction,
- Poor compliance for study protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
Taipei, 112
About this study
Official title: Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora
Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.
- Conditions
- Signs and Symptoms, Digestive
- Being tested
- Yakult®300, Lactobacillus casei strain Shirota
- Keywords
- Probiotics, Lactobacillus, Intestine, Flora
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakult®300Dietary supplement
Yakult®300 was given 100 ml once per day for four weeks.
Fermented or unfermented milk per 100 ml bottle per day for four week.
Lactobacillus casei strain ShirotaDietary supplement
Lactobacillus casei strain Shirota
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fermented milk with Lactobacillus casei strain Shirota 100ml per day Receives: Dietary Supplement: Yakult®300; Dietary Supplement: Lactobacillus casei strain Shirota |
| 2 | Placebo comparator | Unfermented milk without Lactobacillus casei strain Shirota 100ml per day Receives: Dietary Supplement: Yakult®300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Measured: week 0, 1, 2, 3, 4, 5, 6.
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.
Clostridium perfringens was cultured.Bacterial colonies were counted.
Measured: week 0, 1, 2, 3, 4, 5, 6.
Secondary outcomes (1)
Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.
Bacterial colonies were cultured and counted.
Measured: at week 0, 1, 2, 3, 4, 5, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Signs and Symptoms, DigestiveStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng Hsin Rehabilitation Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Hsien Lin, M.D., Principal investigator, Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822328
- Sponsor's protocol ID
- CHGH-IRB(173)97B-13-1
- Status last verified
- Aug 2009
- First submitted
- 9 Jan 2009
- Last updated
- 2 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora
- ClinicalTrials.gov ID
- NCT00822328
- Acronym / sponsor ID
- CHGH-IRB(173)97B-13-1
- Conditions
- Signs and Symptoms, Digestive
- Keywords
- Probiotics, Lactobacillus, Intestine, Flora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cheng Hsin Rehabilitation Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 19 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Yakult®300, Dietary Supplement: Lactobacillus casei strain ShirotaFermented milk with Lactobacillus casei strain Shirota 100ml per day |
| 2 | Placebo comparator | Dietary Supplement: Yakult®300Unfermented milk without Lactobacillus casei strain Shirota 100ml per day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers and willing to give voluntary written informed consent
Key exclusion criteria (8 listed)
- Major systemic disease
- Pregnancy, parturient and feeding woman, or expect to be pregnant
- Abnormal liver function
- Abnormal renal function
- Abnormal gastrointestinal function
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 |
|---|---|---|
| Yakult®300Yakult®300 was given 100 ml once per day for four weeks. Fermented or unfermented milk per 100 ml bottle per day for four week. | Dietary supplement | 1, 2 |
| Lactobacillus casei strain ShirotaLactobacillus casei strain Shirota | Dietary supplement | 1 |
Primary outcome
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Time frame: week 0, 1, 2, 3, 4, 5, 6.
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Time frame: week 0, 1, 2, 3, 4, 5, 6.
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted.
1 secondary outcome
Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota
Time frame: at week 0, 1, 2, 3, 4, 5, 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yi-Hsien Lin, M.D. principal investigator
Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yakult®300 and Lactobacillus casei strain Shirota in people with Signs and Symptoms, Digestive, run by Cheng Hsin Rehabilitation Medical Center at 1 site in Taiwan.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 Sep 2009. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of the Composition of the Intestinal Microflora: Bifidobacterium (time frame: week 0, 1, 2, 3, 4, 5, 6.). The study lists 2 primary outcomes in all. 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 2 Sep 2009.