Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults
Condition: Gastrointestinal Health; Immune Health; Cardiovascular Health; Digestive Health
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the effect of a novel Bacillus subtilis
      spore preparation on abdominal bloating, flatulence, and burping in healthy adults.
    

Detailed description: 
      Probiotics are live microorganisms that, when administered in adequate amounts, confer a
      health benefit on the host. Examples of probiotic health benefits include the support of
      gastrointestinal health, immune health, and mood. Common probiotic strains include species
      from the genera Lactobacillus, Bifidobacterium, and Bacillus. Bacillus species are
      particularly well suited for probiotic applications because they are often manufactured as
      spores that persist without refrigeration and show survivability in the acidic conditions of
      the human gut.

      BIO-CAT Microbials' proprietary Bacillus subtilis BS50 strain ("BS50") has previously been
      shown in bacterial culture to secrete digestive enzymes and candidate gut
      microbiota-modulating molecules which may help support digestion and gastrointestinal health
      (unpublished data). BS50 also showed robust heat resistance and pH tolerance, which predicts
      strain survival across the wide pH range of the human gut. The objective of this clinical
      study is to investigate the effect of BS50 supplementation at 2x10⁹ CFU per day for 42 days
      on abdominal bloating, flatulence, and burping in healthy adults.

      This study will be a randomized, placebo-controlled, parallel design trial consisting of one
      screening visit (Visit 1) and two study visits (Visits 2 and 3). At Visit 1 (Day -7),
      subjects will arrive at the clinic in a fasting state. After subjects provide voluntary
      informed consent, subjects will undergo medical history, prior and current
      medication/supplement use, and inclusion and exclusion criteria assessments. Additionally,
      height, body weight, and vital signs will be measured and BMI will be calculated. Blood
      samples will be collected for chemistry and hematology analyses. Subjects will also be
      dispensed a paper Bowel Habits Diary with Bristol Stool Scale (BHD-BSS) and paper
      Gastrointestinal Tolerance Questionnaire (GITQ) with instructions to capture events occurring
      during the 7 continuous days prior to Visit 2 (Day 0). The GITQ contains a series of
      questions regarding the presence and severity of GI symptoms occurring during the past 24 h.

      At Visit 2 (Day 0), subjects will arrive at the clinic in a fasting state. Subjects will
      undergo clinic visit procedures (concomitant medication/supplement use, assess
      inclusion/exclusion criteria, body weight and vital signs measurements), and adverse event
      (AE) assessment. The paper BHD-BSS and GITQ will be collected and reviewed. To assess sleep
      quality and determine presence and duration of respiratory infection, subjects will be
      instructed to complete a paper Sleep Quality and Respiratory Infection Questionnaire (SQ-RIQ)
      in the clinic. Blood samples will be collected for assessment of markers of intestinal
      permeability, inflammation, and lipid profile. Subjects will be randomly assigned to a study
      product. Subjects will be dispensed their assigned study product and will be instructed to
      consume it once a day (1 capsule/d) for 42 days starting on Day 0. To assess sleep quality
      and determine presence and duration of respiratory infection, subjects will be dispensed a
      weekly electronic SQ-RIQ with instructions to complete this questionnaire weekly prior to
      Visit 3 (Day 42). Subjects will be dispensed the electronic BHD-BSS and electronic GITQ with
      instructions to capture events occurring daily leading up to Visit 3 (Day 42).

      At Visit 3 (Day 42), subjects will arrive at the clinic fasted and undergo clinic visit
      procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body
      weight and vital signs measurements), and adverse event (AE) assessment. Blood samples will
      be collected for chemistry and hematology analyses as well as for assessment of markers of
      intestinal permeability, inflammation, and lipid profile.
    

Intervention name(s): Bacillus subtilis BS50 spore preparation; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will consume 1 capsule containing 2x10⁹ CFU of a Bacillus subtilis BS50 spore preparation once daily for 42 days.; Subjects will consume 1 capsule containing maltodextrin once daily for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotic; Bacillus; subtilis; bloating