Clinical Trial

Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

Study acronym: TrioB
Not Yet Recruiting
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Record status
This record was last updated July 14, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-29.
Trial Details
NCT Number NCT06960941
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Irritable Bowel Syndrome, Metabolic Syndrome
Enrollment 24 participants
Start Date 2025-09
Primary Completion 2026-03 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-14