Could a probiotic ease tummy troubles in seniors?
NCT ID NCT07624656
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a special probiotic supplement in 30 adults aged 50-65 who have ongoing bowel issues like constipation, irritable bowel syndrome, or stomach pain. The goal is to see if the probiotic can improve gut immunity, balance gut bacteria, and ease symptoms like bloating and irregular bowel movements. Researchers will track changes in blood and stool samples over 8 weeks to understand how the probiotic works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1.Diagnosis and Symptom Presentation: Participants must be diagnosed with functional gastrointestinal disorders (FGID) according to Rome IV criteria, including but not limited to: 1. Functional constipation; 2. Irritable bowel syndrome (IBS); 3. Functional abdominal pain syndrome; 4. 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. 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 informed consent, and comply with the study procedures, including scheduled visits and collection of blood and fecal samples. Exclusion Criteria: 1. History or current presence of organic gastrointestinal diseases, such as gastrointestinal malignancy, inflammatory bowel disease (IBD), intestinal obstruction, or intestinal polyps. 2. 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%). 3. 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. 4. Pregnant or breastfeeding women, or those planning pregnancy during the study period. 5. Participation in other clinical trials within 3 months prior to enrollment. 6. Any other health conditions deemed unsuitable for participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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