An interventional study of Functionally Enhanced Limosilactobacillus reuteri Probiotic Preparation in Functional Gastrointestinal Disorders, sponsored by Maanshan Shiqiye Hospital. Not yet recruiting. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Maanshan Shiqiye Hospital · Not applicable, Interventional, and Treatment
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Maanshan Shiqiye Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.Diagnosis and Symptom Presentation: Participants must be diagnosed with functional gastrointestinal disorders (FGID) according to Rome IV criteria, including but not limited to:
2.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.
3.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).
4.General Condition and Compliance: Participants must be able to understand the study purpose, provide written , and comply with the study procedures, including scheduled visits and collection of blood and fecal samples.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: Throughout 8-week 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.
Time frame: Throughout the 8-week 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.
Time frame: Throughout the 8-week intervention period
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for May 2028, 23 months later.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 23 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Maanshan Shiqiye Hospital