Status:
NOT_YET_RECRUITING
Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Irritable Bowel Syndrome
Metabolic Syndrome
Eligibility:
All Genders
50-65 years
Phase:
NA
Brief Summary
The term "inflammaging" describes the aging process characterized by a chronic low-grade inflammatory state. With advancing age, this condition is often associated with cardiovascular disease, diabete...
Detailed Description
Probiotics such as Lactobacillus and Bifidobacterium can interact with immune cells, promoting the synthesis of anti-inflammatory cytokines such as IL-10. Studies have shown that they can significantl...
Eligibility Criteria
Inclusion
- At least two criteria required for the diagnosis of IBS, according to Rome IV criteria (Lacy et al., 2021), namely:
- presence of recurrent abdominal pain on an average of at least 1 day per week in the past 3 months, associated with two (or more) of the following criteria:
- Related to defecation;
- Associated with a change in stool frequency;
- Associated with a change in stool shape/appearance.
- At least two criteria required for the diagnosis of metabolic syndrome, namely:
- impaired blood glucose/insulin resistance;
- Central obesity, waist/hip ratio \> 0.9 in males; \> 0.85 in females; and/or Body Mass Index (BMI) \>30;
- blood pressure ≥ 160/90 or taking antihypertensive drugs;
- HDL cholesterol \< 35 mg/dl in males; \< 39 mg/dl in females;
- triglycerides ≥ 150 mg/dl;
- microalbuminuria \> 20μg/min or albumin/creatinine ratio \> 20mg/g (presence of trace amounts of albumin in urine.
Exclusion
- Hypersensitivity to one or more ingredients;
- Diagnosis of metabolic syndrome;
- Prior history of stroke and/or myocardial infarction;
- Presence of altered mood;
- Presence of kidney or intestinal disease, pancreatitis, diabetes, or any other endocrine disorder;
- Presence of demyelinating and dysmyelinating diseases;
- Inability to provide informed consent.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06960941
Start Date
September 1 2025
End Date
September 1 2027
Last Update
July 14 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168