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.
This single-center, open-label, single-arm interventional study is 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 will be middle-aged and older adults, aged 50-65 years, diagnosed with functional constipation, irritable bowel syndrome, or functional abdominal pain syndrome according to Rome IV criteria. Patients with organic gastrointestinal diseases or severe systemic illnesses will be excluded. Eligible participants will receive the functionally enhanced Limosilactobacillus reuteri probiotic preparation orally, in addition to continuing conventional symptomatic treatment as needed. The probiotic will be administered over a period of 8 consecutive weeks. Participants will be instructed to maintain their usual diet and lifestyle and avoid additional probiotic supplements or antibiotics during the intervention period. Adherence will be monitored through capsule counts at each visit and participant diaries recording intake and any adverse events. Regular assessments will include in-person visits at baseline, Week 4, and Week 8, as well as telephone follow-ups at Weeks 1, 2, and 6 to ensure compliance and capture any tolerability issues. Safety monitoring will include routine laboratory tests (blood count, liver and renal function, and serum biochemical markers) and recording of all adverse events throughout the study period. Primary outcome measures include changes in senescence-associated secretory phenotype (SASP) expression levels, which will be assessed to determine the extent of aging improvement and thereby evaluate intestinal immune aging.Clinical symptoms, including abdominal pain, abdominal distension, bowel movement frequency, and stool form assessed using the Bristol Stool Form Scale, will also be recorded. In addition, gut microbiota composition and key functional bacterial abundance will be analyzed through fecal metagenomic sequencing, along with metabolomic profiling of tryptophan-related metabolites. Safety outcomes include monitoring adverse events and routine laboratory parameters, such as complete blood count, liver and renal function, and serum biochemical indicators. Assessments will be performed at baseline, Week 4, and Week 8, including in-person visits and telephone follow-up to ensure participant compliance and timely collection of samples. Fecal samples will be collected for metagenomic and metabolomic analyses to explore the relationship between probiotic intervention, gut microbiota metabolic function, and intestinal immune aging. This study aims to provide comprehensive evidence for the potential mechanism by which this functionally enhanced probiotic preparation may regulate the gut immune-microbiota network, maintain mucosal barrier integrity, and improve intestinal aging-related microenvironment in elderly patients with functional bowel disorders, thereby informing future clinical application and larger-scale trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The 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.
Time frame: Baseline, Week 4, and Week 8
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.
Time frame: Baseline, Week 4, and Week 8
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.
Time frame: Baseline, Week 4, and Week 8
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.
Time frame: Baseline, Week 4, and Week 8
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.
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Bowel Movement Frequency
Bowel movement frequency will be assessed based on the number of bowel movements per day or per week. Results will be reported as frequency counts and changes from baseline.
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Abdominal Pain Severity Score
Abdominal pain severity will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe abdominal pain and a worse outcome. Results will be reported as scores and changes from baseline.
Time frame: Baseline, Week 4, and Week 8
Change From Baseline in Abdominal Distension Severity Score
Abdominal distension severity will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no abdominal distension and 10 indicates the most severe abdominal distension. Higher scores indicate more severe abdominal distension and a worse outcome. Results will be reported as scores and changes from baseline.
Time frame: Baseline, Week 4, and Week 8
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