TrioB
Evaluation of the Effect of Dietary Supplementation With Probiotics and Prebiotics on Inflammatory Processes, Motor and Cognitive Performance in Patients With Gastrointestinal Disorders.
Sponsor study identifier
interventional
24
1 country
1
Study Start
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2025
Actual (reported)May 7, 2025
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
CRP
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
Change from Baseline PCR at 3 months and at 6 months
Short Physical Performance Battery (SPPB)
Change from Baseline SPPB at 3 months and at 6 months
Timed 25 Foot Walk (T25FW)
Change from Baseline T25FW at 3 months and at 6 months
Timed Up&Go Test (TUG)
Change from Baseline TUG at 3 months and at 6 months
Trail Making Test (TMT)
Change from Baseline TMT at 3 months and at 6 months
Symbol Digit Modalities Test (SDMT)
Change from Baseline SDMT at 3 months and at 6 months
G-TrioB patients, without making any changes to his or her current medication routine, if any, will take 1 sachet of TrioBiotiotix360® daily for 3 months (12 weeks) and will receive a pamphlet with a series of postural hygiene exercises to be performed at home (at least 30 minutes a day, 5 days a week).
G-CON patients will only receive a booklet with a series of postural hygiene exercises to be performed at home (at least 30 minutes a day, 5 days a week) for a period of 3 months.
Dietary supplement combining prebiotics and probiotics to promote the balance of intestinal bacterial microflora.
The booklet will contain a series of postural hygiene exercises to be performed at home
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Silvia Giovannini, MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
April 29, 2025
First Posted
May 7, 2025
Study Start
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Pentabiocel in Pediatric IBS
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
March 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 14, 2025
Record last verified: 2025-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: