Mechanistic investigation of probiotic formula combined with berry extracts on intestinal health in the elderly: a randomised, double-blind, placebo-controlled clinical trial

Description

we carried out a double-blind, placebo-controlled clinical trial to evaluate the protective effects and underlying mechanisms of a compound probiotic product on the gut health of elderly individuals with functional constipation. This study primarily focuses on the changes in intestinal barrier indicators potentially associated with intestinal aging. Simultaneously, constipation-specific and ancillary questionnaires were adopted to evaluate bowel movements and the symptoms induced by constipation. To deeper understand the relationship between gut microbiota and intestinal aging, we carried out the 16S rRNA gene sequencing and ungtageted metabolome at different phases. This research was funded by Amway (Shanghai) Innovation & Science Co., Ltd. , China

Steps to reproduce

This study adopted a multi-index detection approach combined with professional statistical and multi-omics analysis methods, with the core research methods summarized as follows: Sample Collection and Preservation Blood samples were collected at baseline (Week 0) and the end of intervention (Week 8), and fecal samples at Week 0, 4 and 8. Blood samples were pretreated in a clinical laboratory for subsequent biomarker detection; fecal samples were transported on dry ice, stored at -80°C, and used for fecal metabolomic analysis (Week 0 and 8) and gut microbiome analysis (all time points). Outcome Measurement Bowel movement and clinical symptoms: Recorded via daily diaries, with weekly averages for indicator statistics. Quality of life: Evaluated by weekly PAC-SYM and PAC-QOL scales, with fortnightly average scores for analysis. Blood biomarkers: Detected 43 indicators related to liver/kidney function, blood lipids, hematology, inflammation and intestinal barrier function with standardized methods and strict quality control. Fecal microbiome: Analyzed by 16S rRNA gene high-throughput sequencing, including microbial diversity, species annotation, taxonomic and functional prediction. Fecal metabolome: Qualitative and quantitative analysis was conducted by LC-MS/MS technology.

Institutions

• Huazhong University of Science and Technology

  Hubei, Wuhan

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