TrioBiotix360®Booklet with a series of postural hygiene exercises
TrioBiotix360®: Dietary supplement combining prebiotics and probiotics to promote the balance of intestinal bacterial microflora.
Booklet with a series of postural hygiene exercises: The booklet will contain a series of postural hygiene exercises to be performed at home
Study 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, diabetes, and neurodegenerative diseases. Often, the inflammaging state is characterized by environmental factors, such as pollution, diet, and physical inactivity, as well as the accumulation of free radicals and alteration of the gut microbiota. Inflammaging also appears to be linked to irritable bowel syndrome (IBS), a functional gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, and is related to low-grade mucosal inflammation, which may contribute to visceral hypersensitivity and symptom severity.In addition, cytokine activity and alterations in intestinal immune cells would appear to participate significantly in the pathogenesis of IBS. Additionally, there is an independent correlation between IBS and a higher prevalence of metabolic syndrome. Given the multifactorial nature of IBS, no effective treatment has been identified to date. However, considering the central role that alteration of the gut microbiota plays in IBS, the use of prebiotics and probiotics may represent an alternative therapy, as well as help in managing the inflammatory state. Probiotics are live organisms present in the intestinal tract that have the ability to resist the action of digestive enzymes.
Eligibility
Sex
ALL
Min age
50 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
CRP — Change from Baseline PCR at 3 months and at 6 months C-reactive protein (CRP) is an index of inflammation; as such, its blood concentrations increase in the presence of inflammatory processes of various types.
CPR cutoffs are 0-0.5 mg/dL, absence of inflammatory processes; 0.5-1.0 mg/dL, non-acute inflammatory state; 1.0-10 mg/dL: mild or moderate acute inflammation; \> 10 mg/dL, extensive inflammation
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Italy
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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