Trial · NCT06960941
Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.
NCT06960941, Not applicable, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders. Trials, record NCT06960941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06960941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.
- NCT number
- NCT06960941
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Conditions
- Irritable Bowel Syndrome, Metabolic Syndrome
- Interventions
- TrioBiotix360®, Booklet with a series of postural hygiene exercises
- First posted
- 2025-05-07
- Last updated
- 2025-07-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CRP | 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 | Short Physical Performance Battery (SPPB) | Change from Baseline SPPB at 3 months and at 6 months | 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 |
| Secondary | Timed 25 Foot Walk (T25FW) | Change from Baseline T25FW at 3 months and at 6 months | 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. |
| Secondary | Timed Up&Go Test (TUG) | Change from Baseline TUG at 3 months and at 6 months | 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. |
| Secondary | Trail Making Test (TMT) | Change from Baseline TMT at 3 months and at 6 months | 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 |
| Secondary | Symbol Digit Modalities Test (SDMT) | Change from Baseline SDMT at 3 months and at 6 months | 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. |
| Secondary | Stroop Colour Word Test (SCWT) | Change from Baseline SCWT at 3 months and at 6 months | 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. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Change from Baseline HADS at 3 months and at 6 months | 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) |
| Secondary | Modified Fatigue Impact Scale (MFIS) | Change from Baseline MFIS at 3 months and at 6 months | 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. |
| Secondary | EuroQoL- 5D (EQ-5D) | Change from Baseline EQ-5D at 3 months and at 6 months | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06960941
GET https://conductscience.org/api/trials/v1/NCT06960941/registered