Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

NCT ID: NCT06960941

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

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.

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 significantly reduce inflammatory markers such as TNF-α and C-reactive protein (CRP) in conditions such as nonalcoholic hepatic steatosis.

Prebiotics, on the other hand, are substances that are not digestible by the body and are intended to assist the function of probiotics: prebiotics such as β-frucans and galacto-oligosaccharides selectively stimulate beneficial gut bacteria, which can attenuate inflammation in inflammatory bowel disease models. In addition, the production of short-chain fatty acids from prebiotic fermentation is linked to the reduction of systemic inflammation, as shown by decreased CRP levels in subjects consuming different prebiotic mixtures.

The combined use of probiotics and prebiotics, in addition to modulating inflammation, could also influence motor and cognitive function. Recent studies have demonstrated the beneficial effects of probiotics and prebiotics on coordination and motor function in various models, including Parkinson's disease.

Patients referred to the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, who meet the inclusion criteria will be recruited. Patients will be randomly divided into two groups as specified below. One group (G-TrioB), without making any changes to the current therapeutic routine, will take 1 sachet of TrioBiotix360® 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 per day, 5 days per week); the other group (G-CON) will receive only a pamphlet with a series of postural hygiene exercises to be performed at home (at least 30 minutes per day, 5 days per week) for a period of 3 months.

In addition, studies have shown the effect of probiotics on cognitive function, particularly in individuals with mild cognitive impairment and Alzheimer's disease; prebiotics, by enhancing the efficacy of probiotics, may promote a favorable environment for the gut microbiota, which is critical for cognitive health.

Triobiotix360® is a dietary supplement that combines prebiotics and probiotics to support the balance of intestinal bacterial microflora. The prebiotic component is characterized by the presence of Bioecolicans® gluco-oligosaccharide fiber, while the probiotic component is characterized by the presence of Bifidobacterium animalis ssp. Lactis BLC1 (DSM 17741), Lactobacillus acidophilus LA3 (DSM 17742), Lactobacillus rhamnosus IMC 501 (DSM 16104), Lactobacillus paracasei IMC 502 (DSM 16105) and Streptococcusther-mophilus SP4 (DSM 19385). This effect is enhanced by the presence of hyaluronic acid and a mineralized extract of Lithothamnion, a source of calcium, which contributes to the normal functioning of digestive enzymes. Innovative T_win packaging technology preserves the viability of the mixture of 5 different starter culture bacterial strains, selected and blended to maximize product functionality.

Conditions

Irritable Bowel Syndrome; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

G-TrioB

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).

Group Type: EXPERIMENTAL

TrioBiotix360®

Intervention Type: DIETARY_SUPPLEMENT

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

Booklet with a series of postural hygiene exercises

Intervention Type: OTHER

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

G-CON

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.

Group Type: ACTIVE_COMPARATOR

Booklet with a series of postural hygiene exercises

Intervention Type: OTHER

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

Interventions

TrioBiotix360®

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

Intervention Type: DIETARY_SUPPLEMENT

Booklet with a series of postural hygiene exercises

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

GIOVANNINI SILVIA

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Giovannini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Countries

Italy

Central Contacts

Silvia Giovannini, MD, PhD

Role: CONTACT

silvia.giovannini@policlinicogemelli.it

+3906304382

Letizia Castelli, PhD

Role: CONTACT

letizia.castelli@unicatt.it

+390630154382

Facility Contacts

Silvia Giovannini, MD, PhD

Role: primary

silvia.giovannini@policlinicogmelli.it

+390630154382

Letizia Castelli, PhD

Role: backup

letizia.castelli@unicatt.it

+390630154382

Other Identifiers

7272

Identifier Type: -

Identifier Source: org_study_id