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Irritable Bowel SyndromeTrioBNCT06960941

Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

A study testing TrioBiotix360® and Booklet with a series of postural hygiene exercises in people with Irritable Bowel Syndrome and Metabolic Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 65 years
Conditions the study is for
Irritable Bowel Syndrome, Metabolic Syndrome
What is being tested?
TrioBiotix360® and Booklet with a series of postural hygiene exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
Sep 2025to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Silvia Giovannini, MD, PhD contact

+3906304382

silvia.giovannini@policlinicogemelli.it

Letizia Castelli, PhD contact

+390630154382

letizia.castelli@unicatt.it

Italy1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

    Silvia Giovannini, MD, PhD, +390630154382, silvia.giovannini@policlinicogmelli.it

    Letizia Castelli, PhD, +390630154382, letizia.castelli@unicatt.it

Other trials in Italy

About this study

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.

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.

Read the 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.

Being tested
TrioBiotix360®, Booklet with a series of postural hygiene exercises
Keywords
Inflammation, Irritable Bowel Syndrome, Metabolic Syndrome, Nutrition
Medical subject headings
Irritable Bowel Syndrome, Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrioBiotix360®Dietary supplement

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

  • Booklet with a series of postural hygiene exercisesOther

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

Study groups in NCT06960941
Study groupRoleWhat they receive
G-TrioBExperimentalG-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).
Receives: Dietary Supplement: TrioBiotix360®; Other: Booklet with a series of postural hygiene exercises
G-CONActive comparatorG-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.
Receives: Other: Booklet with a series of postural hygiene exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change from Baseline PCR at 3 months and at 6 months

Secondary outcomes (12)
  1. Short Physical Performance Battery (SPPB)

    SPPB is an objective measurement instrument of balance, lower lowerextremity strength, and functional capacity in older adults (>65 years of age). Three domains, which include balance, usual or self-selected gait speed, and lower limb strength, are assessed by a three-stage balance test (feet side-by-side, semitandem, and tandem positions), a 3-m or 4-m gait speed test (time spent to walk the course), and a repetitive chair stand test (five times chair sit-to-stand test), respectively. A 0- to 12-point scale is used to score the sum of the three assessments, with point values corresponding with greater levels of function and lower disability, whereas lower point values correspondwith lower levels of physical function and higher disability, respectively

    Measured: Change from Baseline SPPB at 3 months and at 6 months

  2. Timed 25 Foot Walk (T25FW)

    The T25-FW is a quantitative test of leg mobility and function based on a timed 25-foot walk. The patient is directed to one end of a path and instructed to walk as quickly but safely as possible. The task is immediately repeated by asking the patient to return by walking the same distance. Patients may use assistive devices while performing this task.

    Measured: Change from Baseline T25FW at 3 months and at 6 months

  3. Timed Up&Go Test (TUG)

    TUG measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down.

    The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 5is severely abnormal) according to the observer's perception of the patient's risk of falling.

    The timed part of the test records the mean time (in seconds) from frominitial getting up to re-seating. Patients are compared with the mean time of adults in their age group: 60 to 69, 70 to 79, and 80 to 99 years of age.

    Measured: Change from Baseline TUG at 3 months and at 6 months

  4. Trail Making Test (TMT)

    The TMT measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles are distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.).

    Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

    Trail A: Average 29 seconds, Deficient > 78 seconds, Rule of most in 90 seconds Trail B: Average 75 seconds, Deficient > seconds, Rule of Thumb Most in 3 minutes

    Measured: Change from Baseline TMT at 3 months and at 6 months

  5. Symbol Digit Modalities Test (SDMT)

    The SDMT is a neuropsychological test used to assess cognitive processing speed, attention, and visual-motor coordination. The test involves matching symbols to corresponding numbers based on a key, and participants must quickly and accurately pair the symbols with the correct numbers within a set time limit.

    The test evaluates attention, working memory, and mental flexibility. A higher score indicates better cognitive processing speed and accuracy.

    Measured: Change from Baseline SDMT at 3 months and at 6 months

  6. Stroop Colour Word Test (SCWT)

    ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task and to name colors in the second and third tasks. It is necessary to mark not only any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92.

    Measured: Change from Baseline SCWT at 3 months and at 6 months

  7. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale, the score is the sum of the respective seven items (ranging from 0 to 21).

    The two sub-scales, anxiety and depression, have been found to be beindependent measures. In its current form, the HADS is now divided into four stages:

    Scores of 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)

    Measured: Change from Baseline HADS at 3 months and at 6 months

  8. Modified Fatigue Impact Scale (MFIS)

    The MFIS is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items, while the abbreviated version has 5 items.

    The MFIS is a structured, self-report questionnaire that the patient can cangenerally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument.

    The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.

    Measured: Change from Baseline MFIS at 3 months and at 6 months

  9. EuroQoL- 5D (EQ-5D)

    EQ-5D is an instrument that evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to the ED-5D permit finding 243 unique health states or can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health.

    Measured: Change from Baseline EQ-5D at 3 months and at 6 months

  10. Irritable Bowel Syndrome-Quality of Life (IBS-QOL)

    The IBS-QOL is a self-assessment tool for quality of life. The IBS-QOL consists of 34 items, each with a five-point response scale: from 1 (not at all) to 5 (very much).

    Individual responses to the 34 questions are summed and averaged to obtain a total score, which is then transformed into a scale of 0 to 100 for ease of interpretation, where higher scores indicate better quality of life.

    Measured: Change from Baseline IBS-QOL at 3 months and at 6 months

  11. Silver Index (SI)

    The SI is an objective test to identify the risk of falling, which is carried out using the Hunova robotic platform. It consists of seven domains:

    (i) static balance (ii) dynamic balance (iii) reactive balance (iv) sensory sensoryintegration (v) stability limits (vi) sitting-to-standing position (vii) gait speed.

    At the end of the evaluation, you get a percentage that indicates risk of falling

    Measured: Change from Baseline SI at 3 months and at 6 months

  12. Bioimpedance analysis (BIA)

    BIA measures the opposition of body tissues to alternating current, that is, the impedance of the whole body. The two raw parameters derived from this analysis are resistance (Rz) and reactance (Xc). Rz is inversely related to water content in biological tissues, while Xc depends on the capacitance properties of the cell membrane, providing information on cellular health, integrity, and density From Rz and Xc, the phase angle (PhA), which is related to cellular health and muscle quality, can be calculated directly.

    Lower PhA values have typically been observed in subjects with severe pathological conditions and have been correlated with worse outcomes; in contrast, higher PhA values are indicative of better overall health, strength, and muscle function.

    Measured: Change from Baseline BIA at 3 months and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06960941
Sponsor's protocol ID
7272
Acronym
TrioB
Status last verified
Apr 2025
First submitted
29 Apr 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing TrioBiotix360® and Booklet with a series of postural hygiene exercises in people with Irritable Bowel Syndrome and Metabolic Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Silvia Giovannini, MD, PhD (+3906304382, silvia.giovannini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRP (time frame: Change from Baseline PCR at 3 months and at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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