A Prospective, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy of Bacillus Coagulans Unique IS2 on Improving Bowel Movement Characteristics, Gastrointestinal-related Symptoms and Quality of Life in Healthy Adult Participants

Inclusion Criteria:

1. Healthy male and female adult participants who are 18 to 65 years of age (inclusive).
2. In good general health and good oral health (no active or uncontrolled diseases orconditions).
3. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
4. Have normal (or acceptable to the investigator) vital signs (blood pressure and heartrate) at screening (Visit 1) and baseline (Visit 2) and normal (or acceptable to theinvestigator) physical exam findings (if applicable) at screening.
5. Individuals of childbearing potential must agree to practice a medically acceptableform of birth control for a defined timeframe prior to the start of run-in andthroughout the study to avoid pregnancy, including:
6. use for at least 3 months prior to run-in: hormonal contraceptives including oralcontraceptives, hormone birth control patch (e.g., Ortho Evra), vaginalcontraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g.,Depo-Provera, Lunelle), hormone implant (e.g., Norplant System), or intrauterinedevices (e.g., Mirena); or
7. use for at least 1 month prior to run-in: double-barrier method (e.g., condomwith diaphragm or condom with cervical cap), non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result inpregnancy; or
8. vasectomy of partner at least 6 months prior to run-in. Individuals with thepotential to impregnate others must agree to avoid pregnancy by using thedouble-barrier method mentioned above or complete abstinence from sexualintercourse that can result in pregnancy.
9. Agree to refrain from treatments in the defined timeframes as outlined in Section 6.5.
10. Agree not to change current dietary habits (with the exception of avoiding pro- andprebiotic supplements), smoking and alcohol consumption habits, and activity/traininglevels starting from the beginning of the run-in period and for the duration of thestudy.
11. Agree to avoid anal penetration for 72 hours prior to fecal sample collection.
12. Agree to not receive a vaccine for COVID-19 throughout the duration of the study.
13. Willing and able to agree to the requirements and restrictions of this study, bewilling to give voluntary consent, be able to understand and read the questionnaires,and carry out all study-related procedures.
14. At Visit 2/baseline, based on study diary data, an average of ≥3.0 and <7.0 weekly SBM (occurring without use of laxatives/suppositories/enema/manual maneuvers to defecateon the day of bowel movements or the day before) during the run-in period.
15. At Visit 2/baseline, achieve a study product compliance of 80-120% (inclusive) for therun-in period.

Exclusion criteria:

1. Participants who are lactating, pregnant or planning to become pregnant during thestudy.
2. Have a known sensitivity, intolerability, or allergy to any of the study products ortheir excipients, or not able to take any of the rescue medications.
3. Received a vaccine for COVID-19 in the last 2 weeks prior to screening, currentCOVID-19 infections, or COVID-19 long haulers (those who were first infected withCOVID-19 ≥28 days prior to screening and continue to have symptoms).
4. Current diagnosis or history of irritable bowel syndrome (IBS), constipation (definedas an average of <3 defecations weekly for ≥3 months), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation ordiarrhea (defined by the Rome IV diagnostic criteria), celiac disease, lactoseintolerance and/or malabsorption, gastroparesis, gastroenteritis within the past 60days, endometriosis, diverticulosis, gastric or duodenal ulcers, pancreatitis, oreating disorder; history of intestinal surgery (excluding appendectomy orherniorrhaphy), or history of bariatric surgery.
5. Constipation (defined as <3 defecations on average per week), and/or diarrhea (definedas ≥3 loose or liquid stools/day on any day) during run-in (based on daily diary atVisit 2/baseline).
6. Use of concomitant treatments within the defined timeframes as outlined in Section 6.5.
7. Change of dietary habits (e.g., starting a FODMAP diet, ketogenic diet or fibersupplement use, major increase or major decrease in consumption of high-fiber foods,etc.) within the 4 weeks prior to the beginning of the run-in period.
8. Having a history of heart disease, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), renal or hepatic impairment/disease, uncontrolled diabetes (TypeI or Type II), bipolar disorder, hepatic or renal dysfunction, unstable thyroiddisease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), a history ofcancer (except localized skin cancer without metastases or in situ cervical cancerwithin 5 years prior to screening visit), or a history of any clinically significantdisease or disorder which, in the opinion of the investigator, may either put thepotential subject at risk because of participation in the study, or influence theresults or the potential participant's ability to participate in the study.
9. Major surgery in 3 months prior to screening or planned major surgery during thecourse of the study.
10. History of alcohol or substance abuse, as deemed by the investigator, in the 12 monthsprior to screening.
11. Receipt or use of test product(s) in another research study within 30 days prior torun-in or longer if the previous test product is deemed by the investigator to havelasting effects that might influence the eligibility criteria or outcomes of currentstudy.
12. Any other active or unstable medical conditions or use ofmedications/supplements/therapies that, in the opinion of the investigator, mayadversely affect the participant's ability to complete the study or its measures orpose a significant risk to the participant.