Recruiting
Early Phase 1

LpD3.5

Sponsor:

University of South Florida

Code:

NCT07794956

Conditions

Mild Cognitive Impairment (MCI)

Cognition

Brain Aging

Microbiome Dysbiosis

Leaky Gut Syndrome

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

LpD3.5

Placebo

Study Details

Brief summary:

This randomized placebo-controlled clinical study, called the LpD3.5 Intervention Study in Older Adults (LISA), aims to evaluate whether a heat-inactivated postbiotic of human origin (LpD3.5) can serve as a non-pharmacological intervention to reduce gut permeability and inflammation in older adults with mild cognitive impairment (MCI). The study will assess the effects of LpD3.5 supplementation on markers associated with gut health, inflammation, microbiome composition, and cognitive function.

Participants aged 60 years or older with clinically diagnosed MCI will receive either LpD3.5 capsules or placebo capsules for 60 days, followed by a 30-day follow-up period. Biological samples and clinical assessments will be collected to evaluate changes in gut permeability, inflammatory markers, microbiome characteristics, and cognitive outcomes. The findings from this study may provide insight into the potential role of postbiotics as a dietary intervention to improve gut health and related outcomes in older adults with MCI.

Conditions

Mild Cognitive Impairment (MCI)

Cognition

Brain Aging

Microbiome Dysbiosis

Leaky Gut Syndrome

Study ID

NCT07794956

Start date

Mar 3, 2026

Status verified date

Aug, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

Age 60 years and above; (ii) physician based clinically diagnosed MCI and the Montreal Cognitive Assessment (MoCA) score between 18 and 25; iii) LBP ≥ 30 μg/mL in plasma, and (iv) willing to sign informed consent, take intervention regimen, follow study team guidelines and donate sam-ples, as instructed by the study team; and (iv) live with a partner or care giver

Study partners in this study must meet the following inclusion criteria:

  • Be 60 years or older
  • Willingness to participate in the study and provide consent
  • Ability to have regular contact with the participant(s)
  • Be knowledgeable about the participant's health, memory, and daily activities
  • Communicate effectively in English

Exclusion Criteria:

Brain and gut related surgery within the past 5 years that affected cognitive function: This information will be collected during the initial telephonic screening through an eligibility checklist. (ii) diagnosis of inflammatory bowel disease, ulcerative colitis, Crohn's disease, acid reflux, gastroesophageal reflux disease, Clostridium difficile infection, or any other gastrointestinal disease that might significantly change the microbiome, gut permeability, and inflammation: Participants will be asked about these diagnoses during the telephonic screening, and responses will be documented : Participants will be asked about these diagnoses during the telephonic screening, and responses will be documented. (iii) history of fecal microbiota transplantation and small intestinal bacterial growth: These conditions will also be screened via the initial eligibility questionnaire ad-ministered during the pre-screening phone interview. (iv) history of cancer or cancer treatment in past 5 years: Participants will be asked to report any history of cancer or treatment during the tele-phonic screening (v) nausea, vomiting, food poisoning, constipation, or diarrhea and/or antibiotic use in the past 30 days; These symptoms will be captured via a brief symptom checklist completed at the time of recruitment as well as on-site at the initial study visit. (vi) heavy consumption of pro-biotics, yogurt, or other fermented food (>4 servings per day): Questionnaire on probiotic yogurt, or other fermented food will be administered during the initial screening by telephonic talk as well as on-site visit to capture this information.(vii) critical or terminal illnesses; (viii) having neurological disorders like epilepsy, Parkinson's disease and Amyotrophic lateral sclerosis: These conditions will be assessed via direct questioning during the telephonic pre-screening interview (ix) pregnant or prisoner: Pregnancy status will be determined via verbal confirmation during screening and documented in the eligibility checklist. (x) unable to eat the test product according to the regulations; (xi) participating in other clinical trial; (xii) any diagnosis or condition that renders the subject ineligible at the discretion of the PI and/or the study team.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: LpD3.5 group

This group will receive LpD3.5 (2 capsules per day) for a duration of 60 days with follow-up at 90-day.

placebo comparator: Placebo group

They will receive a bottle of placebo capsules (2 capsules per day) for a duration of 60 days with follow-up at 90 days

Interventions

LpD3.5

LpD3.5 is a human-origin Lactobacillus paracasei strain, a commonly used probiotic species recognized as safe (GRAS). The heat-inactivated postbiotic is produced and packaged in certified facilities for human consumption.

Placebo

Inactive ingredients like maltodextrin; placebo capsules contain only inactive ingredients.

Primary outcome measure

  • Change in Plasma Lipopolysaccharide-Binding Protein (LBP) Level [ Time Frame: Baseline to Day 60 ]

Central Contacts and Locations

Central contacts

Locations

Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute

Recruiting

Tampa, Florida, United States, 33612

Contacts

Hariom Yadav, PhD

8139748222hyadav@usf.edu

Shalini Jain, PhD

jains10@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Postbiotics
  • Microbiome
  • Aging
  • Longevity
  • inflammaging
  • Gut Health
  • Brain Health
  • Leaky Gut
  • Inflammation
  • Probiotics
  • Supplement
  • Dietary
  • Lifestyle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-08-31.