This is a single-center, open-label, single-arm interventional study designed to evaluate the effects of a functionally enhanced Limosilactobacillus reuteri probiotic preparation on intestinal immunity, gut microbiota balance, and intestinal function in elderly patients with functional bowel disorders. Participants aged 50-65 years with functional bowel disorders, including functional constipation, irritable bowel syndrome, or functional abdominal pain syndrome diagnosed according to Rome IV criteria, will receive the probiotic intervention.
The study will assess changes in senescence-associated secretory phenotype (SASP) expression levels to determine the extent of aging improvement, thereby evaluating the impact on intestinal immune aging. Clinical symptoms, including abdominal pain, abdominal distension, bowel movement frequency, and stool form, will also be recorded. In addition, changes in gut microbiota composition, key functional bacteria abundance, and tryptophan metabolites will be analyzed through fecal metagenomic and metabolomic approaches.
Safety and tolerability will be monitored throughout the study by recording adverse events and assessing routine laboratory parameters, including blood count and serum biochemical markers. This study aims to explore the potential mechanisms by which the probiotic preparation may improve gut immune function and microbiota balance, providing evidence for future clinical applications in elderly patients with functional bowel disorders.
Functional constipation;
Irritable bowel syndrome (IBS);
Functional abdominal pain syndrome;
Participants must have clear intestinal dysfunction-related symptoms such as abdominal pain, abdominal distension, difficulty in defecation, or changes in bowel habits, with organic gastrointestinal diseases excluded by clinical evaluation.
History or current presence of organic gastrointestinal diseases, such as gastrointestinal malignancy, inflammatory bowel disease (IBD), intestinal obstruction, or intestinal polyps.
Presence of serious systemic diseases, including severe cardiovascular or cerebrovascular diseases (e.g., myocardial infarction within the past 6 months, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension), significant liver or kidney dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal, estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m²), or uncontrolled diabetes (HbA1c ≥9%).
Use of antibiotics, probiotics, or other drugs significantly affecting gut microbiota within 4 weeks prior to enrollment, or anticipated need to continue these drugs during the study.
Pregnant or breastfeeding women, or those planning pregnancy during the study period.
Single group
Functionally Enhanced Limosilactobacillus reuteri Probiotic Preparation
Dietary supplementThe probiotic preparation is a functionally enhanced Limosilactobacillus reuteri formulation, optimized with peptide prebiotics to improve colonic adhesion and support tryptophan metabolism. This intervention is intended to modulate intestinal immunity and gut microbiota composition. Participants receive the preparation orally over a period of 8 consecutive weeks while maintaining their usual diet and avoiding additional probiotics or antibiotics. Safety monitoring includes routine laboratory tests and recording of any adverse events throughout the study.
Change From Baseline in Concentrations of Senescence-Associated Secretory Phenotype Factors
Senescence-associated secretory phenotype factors will be measured at baseline, Week 4, and Week 8. Results will be reported as concentrations and changes from baseline to evaluate the effect of the functionally enhanced Limosilactobacillus reuteri probiotic preparation on intestinal immune aging-related inflammatory status.
Gut microbiota composition and functional bacteria abundance
Fecal metagenomic analysis to evaluate changes in gut microbiota structure and abundance of key functional bacteria following probiotic intervention.
Change From Baseline in Serum Tryptophan Metabolism Concentrations
Serum concentrations of tryptophan metabolism will be measured using serum metabolomic analysis at baseline, Week 4, and Week 8. Results will be reported as concentrations and changes from baseline. The unit of measure will be reported as serum concentration, such as ng/mL or μmol/L, as appropriate for the analytical method.
Change From Baseline in Fecal Tryptophan Metabolism Concentrations
Fecal concentrations of tryptophan metabolism by gut microbiota will be measured using fecal metabolomic analysis at baseline, Week 4, and Week 8. Results will be reported as concentrations and changes from baseline. The unit of measure will be reported as concentration per fecal sample weight, such as ng/g feces or μmol/g feces, as appropriate for the analytical method.
Change From Baseline in Bristol Stool Form Scale Score
Stool form will be assessed using the Bristol Stool Form Scale. The Bristol Stool Form Scale classifies stool form from Type 1 to Type 7, where Type 1 indicates separate hard lumps and Type 7 indicates watery stool with no solid pieces. Higher scores indicate looser or more watery stool consistency and do not necessarily indicate a better or worse outcome. Results will be reported as scores and changes from baseline.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Treatment-emergent adverse events will be monitored throughout the 8-week intervention period. Results will be reported as the number and percentage of participants experiencing adverse events after initiation of the probiotic intervention.
Number of Participants With Clinically Significant Laboratory Abnormalities
Routine laboratory tests, including complete blood count, liver function, kidney function, and serum biochemical markers, will be performed to assess safety. Results will be reported as the number and percentage of participants with clinically significant laboratory abnormalities during the intervention period.
Number of Participants With Participant-Reported Tolerability Symptoms
Participant-reported tolerability symptoms, including gastrointestinal discomfort or other symptoms potentially related to the probiotic intervention, will be collected throughout the 8-week intervention period. Results will be reported as the number and percentage of participants reporting tolerability symptoms.
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Maanshan Shiqiye Hospital
Lead sponsor
Institute of Process Engineering, Chinese Academy of Sciences
Collaborator
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