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

Launched by YAKULT U.S.A. INC. · Aug 29, 2022

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy men and women between 18-40 years old, inclusive at Visit 1.
• • 2. BMI between ≥18.5 to ≤29.9 kg/m2.
• • 3. Regular bowel habits, by self-report, including consistently having a bowel movement every day, preferably in the morning.
• • 4. Regular breakfast consumer by self-report.
• • 5. Willing to consume the study product per the protocol instructions throughout the study intervention period (14 d).
• • 6. 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.
• • 7. Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/wk throughout the trial.
• • 8. 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.
• • 9. 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.
• • 10. 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.
• • 11. 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:
• • 1. Any known food allergies, intolerances or sensitivities to dairy or to any of the study product ingredients.
• • 2. 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).
• • 3. 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.
• • 4. 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 time), (c) the pain is not feigned, (d) the pain is not related to another GI disorder (e.g., epigastric pain syndrome, irritable bowel syndrome, anorectal pain).
• • 5. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), hepatic, renal (except history of kidney stones in participants who are symptom free for 6 months), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
• • 6. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day 0). One re-test may be allowed on a separate day prior, with repeating of Visit 1, for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day 0), in the judgment of the Clinical Investigator. If taken, the repeat blood pressure measurement will be used to determine eligibility. Stable use of hypertension medication is allowed \[defined as no change in medication regimen within 90 d of Visit 1 (Day 0)\].
• • 7. Weight loss or gain \> 4.5 kg within 90 d of Visit 1 (Day 0), or currently or planning to be on a weight loss regimen or muscle-building/strengthening program during the study.
• • 8. Signs or symptoms of an active infection of clinical relevance within 5 d of Visit 1 (Day 0). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to Visit 1 (Day 0).
• • 9. Major trauma or any other surgical event within 90 d of Visit 1 (Day 0).
• • 10. History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
• • 11. Use of proton pump inhibitors, H2 receptor antagonists, anticoagulants (with the exception of 81 mg aspirin), corticosteroids, antibiotics, antifungals, antiparasitics, antidiarrheals, laxatives, or regular (\> 3 d/wk) use of NSAIDs within 30 d of Visit 1 (Day 0).
• • 12. Exposure to any non-registered drug product within 30 days prior to Visit 1 (Day 0).
• • 13. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception during the study period. The method of contraception must be recorded.
• • 14. Recent history (within 12 mo of screening; Visit 1; Day 0) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks/wk (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• • 15. Recent (within 2 mo) participation in any other clinical study prior to Visit 1 (Day 0).
• • 16. Has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
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