Evaluation of the Effect of Dietary Supplementation With Probiotics and Prebiotics on Inflammatory Processes, Motor and Cognitive Performance in Patients With Gastrointestinal Disorders.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- CRP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: TrioBiotix360® (Dietary Supplement)
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).
Intervention: Booklet with a series of postural hygiene exercises (Other)
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.
Intervention: Booklet with a series of postural hygiene exercises (Other)
Outcomes
Primary Outcomes
CRP
Time Frame: Change from Baseline PCR at 3 months and at 6 months
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
Secondary Outcomes
- 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)
- Stroop Colour Word Test (SCWT)(Change from Baseline SCWT at 3 months and at 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline HADS at 3 months and at 6 months)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline MFIS at 3 months and at 6 months)
- EuroQoL- 5D (EQ-5D)(Change from Baseline EQ-5D at 3 months and at 6 months)
- Irritable Bowel Syndrome-Quality of Life (IBS-QOL)(Change from Baseline IBS-QOL at 3 months and at 6 months)
- Silver Index (SI)(Change from Baseline SI at 3 months and at 6 months)
- Bioimpedance analysis (BIA)(Change from Baseline BIA at 3 months and at 6 months)
Investigators
GIOVANNINI SILVIA
Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS