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

NCT05522777 | Completed Results

• 1 other identifier: BIO-2208
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

probiotics; Lacticaseibacillus paracasei strain Shirota; Colony Forming Unit; survival in GI tract

Outcome Measures

Primary Outcomes (1)

• Change in Live LcS Numbers From Baseline (Day 14) to the End of the Ingestion Period (Day 28).

  The change in Live LcS numbers (CFU/g Feces) from baseline (Visit 2; Day 14) to the end of the ingestion period (Visit 4; Day 28) was measured by colony PCR method.

  14 days

Secondary Outcomes (2)

• Change in LcS Number From Baseline (Day 14) to the Mid of Ingestion Period (Day 21).

  7 days

• Change in LcS Numbers From the End of the Ingestion Period (Day 28) and to the End of Follow-up (Day 42).

  14 days

Study Arms (1)

Test product consumption group

EXPERIMENTAL

Drink one bottle of Yakult a day

Other: Drink one bottle of Yakult a day

Interventions

Drink one bottle of Yakult a day OTHER

Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota

Test product consumption group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 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).
• 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.
• 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 \[defined as no change in medication regimen within 90 d of Visit 1 (Day 0)\].
• 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.
• 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).
• Major trauma or any other surgical event within 90 d of Visit 1 (Day 0).
• History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
• 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).
• Exposure to any non-registered drug product within 30 days prior to Visit 1 (Day 0).
• 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.

Sponsors & Collaborators

• Yakult U.S.A. Inc.: lead
• Biofortis Clinical Research, Inc.: collaborator
• Illinois Institute of Technology: collaborator

Study Sites (1)

Yakult U.S.A. Inc

Fountain Valley, California, 92618, United States

Location

Results Point of Contact

• Title: Hideyuki Shibata
• Organization: Yakult U.S.A. Inc

hideyuki.shibata@yakultusa.com

714-434-6500

Study Officials

• Dawn Beckman, MD

  Biofortis Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: August 15, 2022
• Primary Completion: October 28, 2022
• Study Completion: January 13, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2023-01

Locations

US (1)