Safety and Efficacy of Fecal Microbiota Transplantation on Cognitive Function in T1DM

Condition(s) studied

Investigational drug(s) / intervention(s)

fecal microbiota transplantation: Take fecal microbiota capsules.

Placebo: Take placebo capsules.

Study summary

This study is a prospective, single-center, parallel-design,1:1 randomized controlled trial with triple blinding. It aims to investigate the effects of fecal microbiota transplantation (FMT) on cognitive function in patients with long-term type 1 diabetes (T1D), as well as its effects on other complications, glycemic control, insulin dosage, insulin resistance, peripheral blood immune cells, serum metabolites, and safety. This study is divided into two phases for recruiting participants. The first phase recruits 10 individuals (experimental group: 5, control group: 5), while the second phase recruits 30 individuals (experimental group: 15, control group: 15).The main research objectives are as follows:

1. To observe the difference in cognitive function between the FMT group and the placebo group, with the indicators including cognitive scale scores, changes in brain MRI imaging indicators and brain age at week 24 compared to baseline.
2. To observe the difference in other complications between the FMT group and the placebo group, with the indicators including changes in urinary albumin/creatinine ratio, fundus photography, carotid intima-media thickness, and arterial pulse wave velocity at week 24 compared to baseline.
3. To observe the difference in glycemic control, insulin dosage, insulin resistance, peripheral blood immune cells, gut microbiota, and serum metabolites between the FMT group and the placebo group.
4. To evaluate the safety of FMT.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Trial sites (1)

More Second Xiangya Hospital of Central South University trials in China

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