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

NCT07624656 | Not Yet Recruiting

• 1 other identifier: IPE_Maanshan
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Functionally Enhanced Limosilactobacillus reuteri; Probiotic Intervention; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, and Week 8

Secondary Outcomes (7)

• Gut microbiota composition and functional bacteria abundance

  Baseline, Week 4, and Week 8

• Change From Baseline in Serum Tryptophan Metabolism Concentrations

  Baseline, Week 4, and Week 8

• Change From Baseline in Fecal Tryptophan Metabolism Concentrations

  Baseline, Week 4, and Week 8

• Change From Baseline in Bristol Stool Form Scale Score

  Baseline, Week 4, and Week 8

• Change From Baseline in Bowel Movement Frequency

  Baseline, Week 4, and Week 8

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Throughout 8-week intervention

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Throughout the 8-week intervention period

• Number of Participants With Participant-Reported Tolerability Symptoms

  Throughout the 8-week intervention period

Study Arms (1)

Probiotic Intervention Group

EXPERIMENTAL

All participants receive the functionally enhanced Limosilactobacillus reuteri probiotic preparation orally, in addition to continuing conventional symptomatic treatment as needed. The intervention is administered over a period of 8 consecutive weeks. Participants are instructed to maintain their usual diet and lifestyle and to avoid additional probiotic supplements or antibiotics during the study. Adherence will be monitored through capsule counts and participant diaries recording intake and any adverse events. Clinical assessments include abdominal pain, abdominal distension, bowel movement frequency, and stool form (assessed using the Bristol Stool Form Scale). Blood and fecal samples will be collected at baseline, Week 4, and Week 8 for analysis of intestinal immune function.

Dietary Supplement: Functionally Enhanced Limosilactobacillus reuteri Probiotic Preparation

Interventions

Functionally Enhanced Limosilactobacillus reuteri Probiotic Preparation DIETARY_SUPPLEMENT

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.

Probiotic Intervention Group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis and Symptom Presentation: Participants must be diagnosed with functional gastrointestinal disorders (FGID) according to Rome IV criteria, including but not limited to:
• 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.
• Age and Disease Duration: Participants aged 50-65 years, with relevant symptoms persisting for at least 6 months, and having inadequate response to prior conventional treatment. Conventional treatments include but are not limited to: antidiarrheal agents (e.g., loperamide), gastrointestinal motility regulators (e.g., pinaverium bromide, trimebutine), intestinal microbiota products, or other commonly used drugs to improve diarrhea or regulate bowel function.
• Symptom Severity Assessment: Participants must have a total score of 10-20 on the functional bowel symptom scoring scale as specified in the study protocol (see Appendix).
• General Condition and Compliance: Participants must be able to understand the study purpose, provide written informed consent, and comply with the study procedures, including scheduled visits and collection of blood and fecal samples.

You may not qualify if:

• 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.
• Participation in other clinical trials within 3 months prior to enrollment.
• Any other health conditions deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• Maanshan Shiqiye Hospital: lead
• Institute of Process Engineering, Chinese Academy of Sciences: collaborator

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share