Survival of the Probiotic Lacticaseibacillus Paracasei Strain Shirota (LcS) in the GI Tract of Healthy Adults

Inclusion Criteria

• Healthy men and women between 18-40 years old, inclusive at Visit 1.
• BMI between ≥18.5 to ≤29.9 kg/m2.
• Regular bowel habits, by self-report, including consistently having a bowel movement every day, preferably in the morning.
• Regular breakfast consumer by self-report.
• Willing to consume the study product per the protocol instructions throughout the study intervention period (14 d).
• Willing to maintain habitual dietary, lifestyle, and physical activity (with exceptions per study instructions) throughout the trial and to refrain from exclusionary medications, supplements, and products throughout the study.
• Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/wk throughout the trial.
• Non-user of tobacco products or former user of any tobacco product (not used within 6 months) and has no plan to change nicotine habits during the study period. Tobacco products include tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches) within 6 months of Visit 1 (Day 0) and during the study period.
• Non-user or former user of any marijuana or hemp products (not used within 6 months) of Visit 1 (Day 0) and during the study period and has no plans to use marijuana or hemp products during the study period. No washout is required for topical marijuana or hemp products, but subjects are required to abstain from these products during the study period.
• No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

Exclusion Criteria

• Any known food allergies, intolerances or sensitivities to dairy or to any of the study product ingredients.
• Presence of a clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies). IBS will be determined as recurrent abdominal pain or discomfort at least 3 d/mo in the last 3 mo associated with: (a) improvement with defecation, (b) onset associated with change in frequency of stool, and (c) onset associated with a change in form (appearance of stool).
• Self-reported history (within 6 wks) or presence of functional constipation or diarrhea as defined by the Rome IV criteria and at the discretion of the Clinical Investigator.
• Diarrhea is defined as loose or watery stools, without predominant abdominal pain or bothersome bloating, occurring in more than 25% of stools.
• Constipation is defined as two or more of the following: (a) straining during more than ¼ (25%) of defecations; (b) lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations; (c) sensation of incomplete evacuation more than ¼ (25%) of defecations; (d) sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations; (e) manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor); (f) fewer than 3 single bowel movements/ per week; (g) loose stools are rarely present without the use of laxatives.
• Self-reported history (within 6 wks) or presence of abdominal pain, defined as continuous or nearly continuous pain in the abdominal area in which (a) no or only occasional relationship with physiological events (e.g., eating, defecation, menses), (b) some loss of daily functioning (pain limits activity at least some of the t