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Functionally Enhanced Limosilactobacillus Reuteri Probiotic Preparation in Elderly Patients With Functional Bowel Disorders

NCT07624656 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-03

No results posted yet for this study

Summary

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.

Conditions

  • Functional Gastrointestinal Disorders

Interventions

DIETARY_SUPPLEMENT

Functionally Enhanced Limosilactobacillus reuteri Probiotic Preparation

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.

Sponsors & Collaborators

  • Chinese Academy of Sciences

    collaborator OTHER_GOV

  • Maanshan Shiqiye Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-05-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624656 on ClinicalTrials.gov