Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

NCT06960941 | Not Yet Recruiting

• 1 other identifier: 7272
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Irritable Bowel Syndrome; Metabolic Syndrome

Keywords

Inflammation; Irritable Bowel Syndrome; Metabolic Syndrome; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

Study Arms (2)

G-TrioB

EXPERIMENTAL

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).

Dietary Supplement: TrioBiotix360®; Other: Booklet with a series of postural hygiene exercises

G-CON

ACTIVE COMPARATOR

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.

Other: Booklet with a series of postural hygiene exercises

Interventions

TrioBiotix360® DIETARY_SUPPLEMENT

Dietary supplement combining prebiotics and probiotics to promote the balance of intestinal bacterial microflora.

G-TrioB

Booklet with a series of postural hygiene exercises OTHER

The booklet will contain a series of postural hygiene exercises to be performed at home

G-CON; G-TrioB

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Metabolic Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Giovannini, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Giovannini, MD, PhD

CONTACT

+3906304382; silvia.giovannini@policlinicogemelli.it

Letizia Castelli, PhD

CONTACT

+390630154382; letizia.castelli@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-04

Locations

IT (1)