LpD3.5 Intervention for Gut Health and Cognition in Older Adults with MCI
Official title: A Postbiotics Intervention to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment (Phase 1)
Run by University of South Florida · NCT07794956 · Data updated 2026-11-12
In older adults with mild cognitive impairment, this study tests whether daily LpD3.5 capsules can improve gut health and potentially cognition compared with placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | November 15, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07794956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 60 years or older with physician-diagnosed MCI, MoCA 18-25, elevated plasma LBP, and a willing study partner living with them.
✕Probably not a fit
Participants without gut barrier dysfunction or those unlikely to respond to postbiotic supplementation may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase randomized, placebo-controlled study investigates whether a heat-inactivated human-origin postbiotic, LpD3.5, taken daily for 60 days, can reduce gut permeability and inflammation in adults aged 60 and over with MCI. The trial measures markers of gut barrier function, inflammation, and microbiome changes, along with cognitive outcomes. Participants and caregivers are involved, with a 30-day follow-up and several biological samples collected to explore relationships between gut health and cognition. Exploratory analyses include blood pTau217 and interactions between gut and systemic factors. The study is led by the University of South Florida with collaboration from microbiome research centers in Tampa.
Why it matters
Potential benefit: If successful, the intervention could offer a non-pharmacological option to support gut health and potentially cognitive function in older adults with MCI.
How similar studies have gone: Prior research in this area is exploratory; this trial adapts a postbiotic approach with specific biomarkers to assess feasibility and signal.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
Tampa, Florida, United States Recruiting
Study contacts
- Study coordinator: Hariom Yadav, PhD
- Email: hyadav@usf.edu
- Phone: 8139748222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.