Survival of the Probiotic Lacticaseibacillus Paracasei Strain Shirota (LcS) in the GI Tract of Healthy Adults
Condition: Healthy
MeSH terms: Sprains and Strains
Study type: Interventional

Summary: 
      The objective of this study is to investigate the survival of Lacticaseibacillus paracasei
      strain Shirota (LcS) in the human gastrointestinal (GI) tract after consumption of probiotics
      fermented milk product containing 8x10^9 LcS. This study is a single-arm, open-label study
      with a 14-d run-in (baseline), 14-d consumption period, and 14-d follow-up. Participants will
      maintain habitual dietary and lifestyle practices with the exception of avoiding fermented
      foods and beverages throughout the 42-d trial. The number of live LcS in fecal samples will
      be assessed after 14 d consumption of a fermented milk product.
    

Detailed description: 
      The study is a single-arm, open-label study with one screening visit (Visit 1; Day 0), one
      baseline visit (Visit 2; Day 14), two intervention visits (Visits 3 and 4; Days 21 and 28),
      and one post-intervention follow-up visit (Visit 5; Day 42).

      After signing the informed consent, participants will be screened for eligibility. All women
      will be required to take an in-clinic urine pregnancy test. After review of inclusion/
      exclusion criteria, eligible participants will then be enrolled in the study and start a 14-d
      run-in period. Eligible participant will be instructed to continue with their habitual diets
      and lifestyle patterns, with exception of excluding fermented dairy and non-dairy products. A
      Stool Collection Demonstration will be conducted and participants will be provided a stool
      collection kit, along with ice packs. Participants will be instructed to collect a stool
      sample sometime after 7 pm the day before and prior to their next visit (Visit 2; Day 14).
      Participants will also be instructed on the electronic Daily Diary, which asks compliance
      with study instructions to avoid fermented products as well as questions on concomitant
      medication intake. Visit 2 (Day 14) is the end of the run-in and start of the ingestion
      period. At Visit 2, participants will arrive in the morning, undergo clinic procedures. Stool
      samples will be collected (Day 14 samples), and the eDiaries reviewed as appropriate.
      Additionally, participants will be queried about following the study instructions provided at
      Visit 1. The first serving of study product will be consumed during the clinic visit after
      participants have consumed breakfast (at home) and obtained and dropped off their stool
      samples. Participants will then be dispensed two 5-packs of study product for at-home daily
      consumption until the next visit (Visit 3; Day 21) and instructed to consume one bottle of
      the study product within the 30 minutes following breakfast, and to keep all dispensed
      product refrigerated prior to consumption. A new stool collection kit with fecal sample
      storage materials will be provided and participants instructed to collect a stool sample
      sometime after 7 pm the day before and prior to their next visit (Visit 3; Day 21).
      Participants will be reminded to maintain their habitual dietary and lifestyle patterns and
      refrain from consumption of any other fermented dairy and non-dairy products, consume their
      study product daily, and complete their eDiaries every day. The eDiary will contain the same
      questions as during the run-in plus queries on daily product consumption, which will then be
      used for compliance assessment. Adverse events (AE) will be assessed by open-ended question
      at the beginning and end of Visit 2 (Day 14) and at the beginning of Visits 3, 4, and 5 (Days
      21, 28, and 42, respectively). Participants will be counseled to contact the clinic with
      concerns or discomforts. If participants miss consuming study product in the morning, they
      should be counseled to consume the product as soon as possible during that day; however,
      participants should not consume more than one serving of product per day. Therefore, if they
      miss consuming the product during the entire day, they should document the lack of study
      product consumption and continue consuming one serving per day. Following the first seven
      days of the ingestion period, participants will return for an interim visit (Visit 3; Day 21)
      to drop off their stool sample (Day 21 sample) and to obtain a new stool collection kit.
      Participants will be instructed to collect another stool sample (Visit 4; Day 28). The eDiary
      will be reviewed, including product consumption compliance, and participants will be queried
      about following the study instructions. AEs will be assessed. Participants will return unused
      study product and be dispensed new study product to continue at-home daily consumption, with
      reminder to consume one serving per day until the next visit. Participants will also be
      reminded to continue to maintain habitual dietary and lifestyle patterns while avoiding
      fermented dairy and non-dairy products, as well as to complete their eDiaries every day. At
      the end of the ingestion period, participants will return for Visit 4 (Day 28) to drop off
      their stool sample (Day 28 sample) and return unused study product. Clinic procedures will be
      performed, AEs assessed, and electronic Daily Diaries and compliance will be reviewed. At
      this point, participants will be instructed that will no longer need to consume study product
      and will enter the follow-up period. Participants will be dispensed a new stool collection
      kit and instructed to collect a final stool sample (Visit 5; Day 42). Participants will also
      be reminded to continue to maintain habitual dietary and lifestyle patterns while avoiding
      fermented dairy and non-dairy products as well as to complete their eDiaries every day.
      Participants will return for their final visit (Visit 5; Day 42) after collection of their
      follow-up stool sample (Day 42 sample). Participants will drop off their final stool sample.
      Clinic visit procedures will be conducted, AEs assessed, and participants will be queried
      about following study instructions. eDiaries will be reviewed as appropriate. Participants
      will then be discharged from the study.
    

Intervention name(s): Drink one bottle of Yakult a day
Intervention type(s): Other
Intervention description(s): Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: probiotics; Lacticaseibacillus paracasei strain Shirota; Colony Forming Unit; survival in GI tract