A Novel Probiotic Fermented Milk Drink to Improve Gut and Brain Health in Older Floridians and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Gut Microbiome Shannon Diversity Index
研究概览
简要总结
This double-blind, randomized, placebo-controlled clinical trial will evaluate the effects of a probiotic fermented milk (PFM) drink on gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. Up to 40 participants will be enrolled.
Participants will be randomly assigned to consume either the PFM drink or a matched placebo daily for 30 days. The primary objective is to determine whether PFM consumption improves gut microbiome abnormalities. Secondary objectives include evaluating effects on nutrient absorption, gut microbiome diversity and composition, and systemic inflammation. The study will also explore relationships between changes in nutrient absorption, microbiome profiles, inflammation, and behavioral outcomes in participants with ADRD and their caregivers.
Each participant will participate in the study for approximately 30 days. This pilot study is intended to generate preliminary clinical and biological data regarding the potential role of probiotic nutrition in supporting gut and brain health and to inform the design of future larger clinical trials.
详细描述
This pilot clinical trial will investigate the effects of a human-origin probiotic fermented milk (PFM) beverage on biological pathways related to gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. The study is based on evidence suggesting that alterations in the gut microbiome, nutrient metabolism, and systemic inflammation may be associated with cognitive and behavioral health and may represent modifiable targets in ADRD.
Participants with ADRD and their caregivers will be enrolled as patient-caregiver dyads and independently randomized to receive either the PFM intervention or a matched placebo for 30 days. The PFM contains four human-origin probiotic strains: Limosilactobacillus reuteri HL278, Lactiplantibacillus plantarum HL279, Lacticaseibacillus paracasei HL260, and Lactiplantibacillus plantarum HL82.
Biological assessments will be performed before and after the intervention to characterize changes in the gut microbiome, nutrient-related measures, and systemic inflammation. Fecal microbiome composition will be evaluated using metagenomic sequencing and bioinformatics approaches to examine microbial diversity and taxonomic composition. Blood- and stool-based laboratory analyses will be used to assess selected nutrient and inflammatory biomarkers.
Clinical and behavioral measures will also be evaluated to explore whether biological changes associated with the intervention are related to measures of health, quality of life, agitation, stress, or anxiety in participants with ADRD and their caregivers. Analyses will compare changes between the PFM and placebo groups and explore relationships among microbiome characteristics, nutrient-related measures, inflammatory markers, and behavioral outcomes.
The study is intended to generate preliminary information regarding the biological effects and feasibility of the PFM intervention and to provide data that may inform the design of larger future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind, randomized, placebo-controlled clinical trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ADRD and accompanied with their caregiver
- •Age ≥ 18 years old
- •Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form
排除标准
- •Lactose intolerance or another intolerance that prevents the safe consumption of dairy products
- •Allergy to any ingredients in the PFM formulations, including almonds/nuts, lactose/dairy, dextrose, artificial sweeteners, or dyes used in flavoring
- •Known allergy or hypersensitivity to peanuts or soy, as indicated on the pectin product label.
- •Known allergy, intolerance, or hypersensitivity to Ensure® or any of its components.
- •Cancer patients receiving chemotherapy, due to potential increased risk of infection from GI tract damage
- •Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome. Data collected prior to antibiotic use may be retained, and withdrawn participants will be replaced to maintain the target sample size.
- •Major surgery(ies) of the gut or brain within the past five years
- •Diagnosis of inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, acid reflux, gastroesophageal reflux disease (GERD), Clostridium difficile infection (CDI), or any other gastrointestinal disease that could significantly change the microbiome History of fecal microbiota transplantation
- •Small intestinal bacterial overgrowth
- •History of anticipatory nausea, vomiting, constipation, or diarrhea
- •Antibiotic or probiotic or heavy yogurt (3 servings per day) use within the past 30 days
- •o Probiotic use is defined as consumption of ≥108 CFU/day, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiotics are a major ingredient
- •Critical or terminal illnesses including diabetes
- •Pregnant women will be excluded from the study based on self-report during the screening process. No pregnancy testing kits will be provided, and pregnancy testing will not be performed as part of this study. Therefore, individuals who are currently pregnant are excluded from participation.
- •Significant mental health conditions
研究组 & 干预措施
Probiotics fermented milk
Participants will receive two 4-ounce servings of a probiotic fermented milk (PFM) drink daily for 30 days. The PFM drink contains probiotic strains intended to support gut microbiome balance, nutrient absorption, and gut-brain health.
Participants will receive two 4-ounce servings of a placebo drink daily for 30 days. The placebo drink is matched in taste, appearance, and volume but does not contain active probiotic components.
干预措施: Probiotic Fermented Milk (PFM) Drink (Dietary Supplement)
Probiotics fermented milk
Participants will receive two 4-ounce servings of a probiotic fermented milk (PFM) drink daily for 30 days. The PFM drink contains probiotic strains intended to support gut microbiome balance, nutrient absorption, and gut-brain health.
Participants will receive two 4-ounce servings of a placebo drink daily for 30 days. The placebo drink is matched in taste, appearance, and volume but does not contain active probiotic components.
干预措施: Placebo (Dietary Supplement)
Placebo milk
ADRD and caregivers
干预措施: Probiotic Fermented Milk (PFM) Drink (Dietary Supplement)
Placebo milk
ADRD and caregivers
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Gut Microbiome Shannon Diversity Index
时间窗: Baseline and Day 30
Change in gut microbiome alpha diversity from baseline to Day 30, quantified using the Shannon diversity index derived from whole-genome shotgun metagenomic sequencing of stool samples. A single change value will be calculated for each participant as the Day 30 Shannon diversity index minus the baseline Shannon diversity index. Unit of Measure: Shannon diversity index
次要结局
- Change in Stool Lipocalin-2 Concentration(Baseline and Day 30)
- Change in Stool Calprotectin Concentration(Baseline and Day 30)
- Change in Serum Monocyte Chemoattractant Protein-1 Concentration(Baseline and Day 30)
- Change in Serum Interleukin-1 Beta Concentration(Baseline and Day 30)
- Change in Serum Tumor Necrosis Factor-Alpha Concentration(Baseline and Day 30)
- Change in Serum Interleukin-6 Concentration(Baseline and Day 30)
- Change in Serum C-Reactive Protein Concentration(Baseline and Day 30)
- Change in Serum Zinc Concentration(Baseline and Day 30)
- Change in Serum Iodine Concentration(Baseline and Day 30)
- Change in Serum Magnesium Concentration(Baseline and Day 30)
- Change in Serum Folate Concentration(Baseline and Day 30)
- Change in Serum Vitamin D3 Concentration(Baseline and Day 30)
- Change in Serum Vitamin B12 Concentration(Baseline and Day 30)
- Gut Microbiome Beta Diversity Assessed by Bray-Curtis Dissimilarity(Baseline and Day 30)
- Change in EQ-5D Index Score in ADRD Participants(Baseline and Day 30)
- Change in Cohen-Mansfield Agitation Inventory Total Score(Baseline and Day 30)
- Change in Perceived Stress Scale Total Score in Caregivers(Baseline and Day 30)
- Change in State-Trait Anxiety Inventory State Anxiety Score(Baseline and Day 30)
- Change in State-Trait Anxiety Inventory Trait Anxiety Score(Baseline and Day 30)