Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM
NCT06496412, Not applicable, Recruiting, Second Xiangya Hospital of Central South University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM | ClinicalTrials.gov |
| NCT number | NCT06496412 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Second Xiangya Hospital of Central South University | ClinicalTrials.gov |
| Conditions | Type 1 Diabetes | ClinicalTrials.gov |
| Interventions | fecal microbiota transplantation, Placebo | ClinicalTrials.gov |
| First posted | 2024-07-11 | ClinicalTrials.gov |
| Last updated | 2024-07-11 | ClinicalTrials.gov |
Registered outcomes 38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cognition:Comparison of the average change in Z-scores for memory and executive domain-related assessments between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Z-scores of memory and executive domain assessments-related assessments are indicators that can comprehensively reflect cognitive function. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Auditory Verbal Learning Test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Auditory Verbal Learning Test (AVLT) is a neuropsychological assessment tool used to evaluate an individual's verbal learning and memory skills. This test involves the presentation of a list of words to the test subject, who is then asked to recall as many words as possible from the list after a single exposure. The process is typically repeated several times, allowing the examiner to assess the subject's ability to learn new information and retain it over time. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Trail Making Test Part A and Part B between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts, A and B. Participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. 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. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Verbal Fluency Test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Verbal Fluency Test (VFT) is a common neuropsychological assessment used to evaluate an individual's cognitive flexibility and generative language abilities. It typically involves asking the participant to produce as many words as possible within a certain time limit, usually one minute, that fit a specific criterion. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Boston Naming Test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Boston Naming Test (BNT) is a widely used neuropsychological instrument designed to assess an individual's confrontational naming abilities, which is a critical aspect of language function. The test consists of a series of line drawings of objects, animals, and people, each paired with a prompt that encourages the participant to name the item. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Stroop Color- Word Association Test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Stroop Color- Word Association Test is particularly useful in assessing executive functions, such as selective attention and cognitive flexibility. It is sensitive to the effects of various conditions that impact cognitive control, including attention deficit hyperactivity disorder (ADHD), Alzheimer's disease, Parkinson's disease, and substance abuse disorders. The test can also be used to evaluate the effectiveness of cognitive training programs and to monitor changes in cognitive function over time. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Symbol Digit Modalities Test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Symbol Digit Modalities Test (SDMT) is a brief neuropsychological screening tool designed to assess cognitive processing speed and attention. The SDMT is scored based on the number of correct responses within the time frame, providing a quantitative measure of cognitive performance. It is particularly sensitive to changes in cognitive function that may occur with aging, as well as in conditions such as multiple sclerosis, Parkinson's disease, traumatic brain injury, and Alzheimer's disease. The test is often used to monitor the progression of cognitive decline and to evaluate the effectiveness of treatments. The SDMT is also valuable in differentiating between different types of cognitive impairments and can be used as part of a comprehensive neuropsychological assessment to provide a more detailed picture of an individual's cognitive strengths and weaknesses. Its brevity and ease of administration make it a practical tool for repeated assessments over time. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Clock drawing test between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Clock Drawing Test (CDT) is a widely used neuropsychological screening tool that assesses an individual's cognitive function, particularly in the areas of executive function, visual-spatial skills, and constructional praxis. It is a simple yet effective test that requires participants to draw a clock face and then set the hands to indicate a specific time, often 10 minutes past 11. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in MOCA between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Montreal Cognitive Assessment (MOCA) is a rapid screening tool for mild cognitive dysfunction, particularly useful in identifying early signs of cognitive impairment associated with conditions such as Alzheimer's disease and other forms of dementia.The test is sensitive to changes in cognitive function that may not be detected by less detailed assessments, making it a valuable tool for both clinical and research settings. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Subjective Cognitive Decline 9 between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Subjective Cognitive Decline 9 (SCD9) is a tool designed to assess an individual's perception of changes in their cognitive abilities over time. It is particularly useful for identifying early signs of cognitive decline that may be indicative of the onset of neurodegenerative diseases such as Alzheimer's disease. The development of the SCD9 questionnaire aims to provide a localized, sample-assisted, multi-domain instrument that can be used to evaluate subjective cognitive decline in the elderly population over the past 1-2 years. The scale has demonstrated good reliability and validity, with a confirmatory factor analysis supporting a 4-factor model that includes memory, attention, executive function, and language domains. | ClinicalTrials.gov |
| Primary | Cognition: Comparison of the average change in Brain MRI between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Brain MRI, particularly structural Structural MRI, Diffusion MRI(DTI), and Functional MRI (fMRI), plays a crucial role in understanding cognitive functions. Structural MRI can identify anatomical correlates of cognitive deficits, while DTI provides insights into the integrity of neural pathways essential for cognitive processing. fMRI allows researchers to observe brain activity during various cognitive tasks, offering a direct link between brain function and cognition. This comprehensive approach enables clinicians and researchers to explore the neural basis of cognitive functions and disorders, enhancing diagnosis and treatment strategies. | ClinicalTrials.gov |
| Secondary | Safety: Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest. | from baseline to week 24 | Proportion of participants with treatment-related adverse events, serious adverse events, or adverse events of special interest. Adverse events, serious adverse events, or adverse events of special interest, will be evaluated following study procedures using AE and SAE forms, telephone and in person interview, and relevant medical records related to adverse events. | ClinicalTrials.gov |
| Secondary | macrovascular complications：Comparison of the average change in Carotid Intima-Media Thickness between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Carotid Intima-Media Thickness is a valuable indicator of subclinical atherosclerosis and a predictor of cardiovascular and cerebrovascular events. It is typically measured using high-resolution B-mode ultrasonography, which provides images of the carotid artery walls. The measurement is taken from the leading edge of the lumen-intima interface to the leading edge of the media-adventitia interface on the far wall of the carotid artery. | ClinicalTrials.gov |
| Secondary | macrovascular complications：Comparison of the average change in Arterial Pulse Wave Velocity between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Arterial Pulse Wave Velocity (PWV) is a measure of the speed at which blood pressure waves move through the arteries. It is an important indicator of arterial stiffness, with higher values indicating stiffer arteries, which are often associated with cardiovascular risk. | ClinicalTrials.gov |
| Secondary | macrovascular complications：Comparison of the average change in Ankle-Brachial Index between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess the presence of peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery). ABI is also a marker for overall cardiovascular health. A low ABI is associated with an increased risk of heart attack, stroke, and overall cardiovascular mortality. | ClinicalTrials.gov |
| Secondary | microvascular complications：Comparison of the average change in Albumin-to-Creatinine Ratio between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Albumin-to-Creatinine Ratio (ACR) is a diagnostic test used to detect and monitor kidney function, particularly to identify early signs of kidney damage. It measures the amount of albumin (a type of protein) in the urine, normalized to the amount of creatinine (a waste product of muscle metabolism) to account for variations in urine concentration. | ClinicalTrials.gov |
| Secondary | microvascular complications：Comparison of the average change in Estimated Glomerular Filtration Rate between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Estimated Glomerular Filtration Rate (eGFR) is a key indicator of kidney function. It estimates the rate at which the kidneys filter waste products from the blood, providing valuable information about renal health and helping to diagnose and monitor kidney disease. | ClinicalTrials.gov |
| Secondary | microvascular complications：Compare the differences in the proportion of abnormal fundus photography and the severity of progression between the experimental and control groups during the follow-up period. | from baseline to week 24 | Fundus photography is a non-invasive diagnostic procedure used to capture images of the retina at the back of the eye. This technique is essential for the early detection, evaluation, and monitoring of diabetic retinopathy and other vascular changes in the eye, which can be indicative of diabetes-related complications. | ClinicalTrials.gov |
| Secondary | microvascular complications：Comparison of the average change in Neuropathy lmpairment Score in the Lower Limbs between the experimental and control groups from baseline to week 24. | from baseline to week 24 | The Neuropathy Impairment Score in the Lower Limbs (NIS-LL) is a clinical tool used to evaluate the severity of neuropathy, specifically in the lower extremities. This score helps in assessing the degree of nerve damage and its impact on motor and sensory functions. The NIS-LL takes into account the following components. | ClinicalTrials.gov |
| Secondary | Glycemic control：Comparison of the average change in Hemoglobin A1c between the experimental and control groups from baseline to week 24. | from baseline to week 24 | Hemoglobin A1c (HbA1c) is a blood test that measures the average level of blood glucose (sugar) over the past two to three months. It is a key indicator used to diagnose and manage diabetes. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
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 |
|---|---|---|
| Clock Drawing Task | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)