Clinical trial NCT06960941: Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.
Official title: Evaluation of the Effect of Dietary Supplementation With Probiotics and Prebiotics on Inflammatory Processes, Motor and Cognitive Performance in Patients With Gastrointestinal Disorders.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Metabolic Syndrome
Keywords: Inflammation
Irritable Bowel Syndrome
Metabolic Syndrome
Nutrition
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CRP
timeFrame: Change from Baseline PCR at 3 months and at 6 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 3 months and at 6 months
measure: Timed 25 Foot Walk (T25FW)
timeFrame: Change from Baseline T25FW at 3 months and at 6 months
measure: Timed Up&Go Test (TUG)
timeFrame: Change from Baseline TUG at 3 months and at 6 months
measure: Trail Making Test (TMT)
timeFrame: Change from Baseline TMT at 3 months and at 6 months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 3 months and at 6 months
measure: Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline SCWT at 3 months and at 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline HADS at 3 months and at 6 months
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 3 months and at 6 months
measure: EuroQoL- 5D (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 3 months and at 6 months
measure: Irritable Bowel Syndrome-Quality of Life (IBS-QOL)
timeFrame: Change from Baseline IBS-QOL at 3 months and at 6 months
measure: Silver Index (SI)
timeFrame: Change from Baseline SI at 3 months and at 6 months
measure: Bioimpedance analysis (BIA)
timeFrame: Change from Baseline BIA at 3 months and at 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: