Gut MicrobiotaNCT03991195
Intervention of Intestinal Microorganism in Mild Cognitive Impairment
A study testing Probiotic supplemented intervention in people with Gut Microbiota and Mild Cognitive Impairment, run by XuanwuH 2 at 1 site in China.
Trial summary
Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Dysbiosis of the gut microbiota is considered to be associated with AD, and probiotic supplementation may positively affect cognitive function. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Gut Microbiota, Mild Cognitive Impairment, Dementia, Alzheimer Type
- What is being tested?
- Probiotic supplemented intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of patients with aMCI: memory loss complaint confirmed by an informant; objective cognitive impairment in single or multiple domains, adjusted for age and education; preserved general cognitive function; failure to meet the criteria for dementia; the clinical dementia rating (CDR) score is 0.5.
- Clinical diagnosis of patients with subjective cognitive decline (SCD): presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; failure to meet the following criteria for MCI.
- Clinical diagnosis of the control group: no complaint of memory loss; CDR score is 0; no severe visual or auditory impairment.
Who cannot join
- a history of stroke;
- major depression (Hamilton Depression Rating Scale score > 24 points);
- other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- a history of psychosis or congenital mental growth retardation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurolgy, Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Regulatory Mechanism of Intestinal Microorganism in Intervening Mild Cognitive Impairment Based on Multi-modal Neuroimaging Techniques
Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Dysbiosis of the gut microbiota is considered to be associated with AD, and probiotic supplementation may positively affect cognitive function. However, there are few studies involving the relationship between intestinal microorganism and amnestic mild cognitive impairment (aMCI). In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take certain Bifidobacterium for a certain time. After that, the investigators aim to investigate the improvement of cognitive function and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S recombinant deoxyribonucleic acid (rDNA) high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks. In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiota as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
Read the detailed description
Dysbiosis of the gut microbiota is considered to be associated with Alzheimer's disease (AD), and probiotic supplementation may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of gut microbiota in possible intervention for amnestic mild cognitive impairment (aMCI).
In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. The control group with aMCI will take placebo. After that, the investigators aim to investigate the differences of cognitive function between these two groups and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S rDNA high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, including structural magnetic resonance imaging (sMRI）, functional MRI, diffusion tensor imaging (DTI)， functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks.
In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiome as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
- Being tested
- Probiotic supplemented intervention, Placebo
- Keywords
- mild cognitive impairment, intestinal microorganism, regulation, magnetic resonance imaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplemented interventionDietary supplement
In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. After that, cognitive changes will be test to investigate the effectiveness of probiotic supplementation.
PlaceboDietary supplement
In this project, taking the method of random, double blindness and control, the placebo group with aMCI will take placebo for three months. After that, cognitive changes will be test.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplemented group with aMCI | Experimental | Thirty participants in this group will take Bifidobacterium for three months. Receives: Dietary Supplement: Probiotic supplemented intervention |
| Placebo group with aMCI | Placebo comparator | Thirty participants in this group will take placebo for three months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Montreal cognitive assessment (MoCA)
After intervention for three months, the investigators first aim to compare cognitive changes of Montreal cognitive assessment (MoCA) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Measured: Three months
Improvement of Auditory Verbal Learning Test (AVLT)
After intervention for three months, the investigators will then compare cognitive changes of Auditory Verbal Learning Test (AVLT) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Measured: Three months
Changes of intestinal microbial flora diversity
After intervention for three months, the investigators will further compare the diversity changes of intestinal microbial flora, such as Lactobacteria species, Bifidobacterium, Enterococci, Propionobacteria, Peptostreptococci, etc., among three groups.
Measured: Three months
Secondary outcomes (3)
Structural MRI-based brain network changes
After intervention for three months, the investigators will compare the structural changes of brain network among three groups (e.g., efficiency, clustering, modularity) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Measured: Three months
Functional MRI-based brain network changes
After intervention for three months, the investigators will compare the functional changes of brain network among three groups (e.g., functional connectivity, hub) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Measured: Three months
FNIRS-based brain network changes
After intervention for three months, the investigators will compare the functional changes of brain network among three groups (e.g., functional connectivity, small word, efficiency) in order to reveal the regulatory mechanism of intestinal microorganism in intervening aMCI.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start31 Aug 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of Tsinghua University, Beijing Normal University
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
- Investigators
- Ying Han, PhD, Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991195
- Sponsor's protocol ID
- HanYingsc
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information of neuropsychological tests, neuroimaging data are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Mechanism of Intestinal Microorganism in Intervening Mild Cognitive Impairment Based on Multi-modal Neuroimaging Techniques
- ClinicalTrials.gov ID
- NCT03991195
- Acronym / sponsor ID
- HanYingsc
- Keywords
- mild cognitive impairment, intestinal microorganism, regulation, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Collaborators
- First Hospital of Tsinghua University, Beijing Normal University
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Dysbiosis of the gut microbiota is considered to be associated with AD, and probiotic supplementation may positively affect cognitive function. However, there are few studies involving the relationship between intestinal microorganism and amnestic mild cognitive impairment (aMCI). In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take certain Bifidobacterium for a certain time. After that, the investigators aim to investigate the improvement of cognitive function and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S recombinant deoxyribonucleic acid (rDNA) high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks. In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiota as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
Detailed description
Dysbiosis of the gut microbiota is considered to be associated with Alzheimer's disease (AD), and probiotic supplementation may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of gut microbiota in possible intervention for amnestic mild cognitive impairment (aMCI).
In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. The control group with aMCI will take placebo. After that, the investigators aim to investigate the differences of cognitive function between these two groups and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S rDNA high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, including structural magnetic resonance imaging (sMRI）, functional MRI, diffusion tensor imaging (DTI)， functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks.
In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiome as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplemented group with aMCI | Experimental | Dietary Supplement: Probiotic supplemented interventionThirty participants in this group will take Bifidobacterium for three months. |
| Placebo group with aMCI | Placebo comparator | Dietary Supplement: PlaceboThirty participants in this group will take placebo for three months. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of patients with aMCI: memory loss complaint confirmed by an informant; objective cognitive impairment in single or multiple domains, adjusted for age and education; preserved general cognitive function; failure to meet the criteria for dementia; the clinical dementia rating (CDR) score is 0.5.
- Clinical diagnosis of patients with subjective cognitive decline (SCD): presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; failure to meet the following criteria for MCI.
- Clinical diagnosis of the control group: no complaint of memory loss; CDR score is 0; no severe visual or auditory impairment.
Key exclusion criteria (6 listed)
- a history of stroke;
- major depression (Hamilton Depression Rating Scale score > 24 points);
- other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic supplemented interventionIn this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. After that, cognitive changes will be test to investigate the effectiveness of probiotic supplementation. | Dietary supplement | Probiotic supplemented group with aMCI |
| PlaceboIn this project, taking the method of random, double blindness and control, the placebo group with aMCI will take placebo for three months. After that, cognitive changes will be test. | Dietary supplement | Placebo group with aMCI |
Primary outcome
Improvement of Montreal cognitive assessment (MoCA)
Time frame: Three months
After intervention for three months, the investigators first aim to compare cognitive changes of Montreal cognitive assessment (MoCA) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Improvement of Auditory Verbal Learning Test (AVLT)
Time frame: Three months
After intervention for three months, the investigators will then compare cognitive changes of Auditory Verbal Learning Test (AVLT) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.
Changes of intestinal microbial flora diversity
Time frame: Three months
After intervention for three months, the investigators will further compare the diversity changes of intestinal microbial flora, such as Lactobacteria species, Bifidobacterium, Enterococci, Propionobacteria, Peptostreptococci, etc., among three groups.
3 secondary outcomes
Structural MRI-based brain network changes
Time frame: Three months
Functional MRI-based brain network changes
Time frame: Three months
FNIRS-based brain network changes
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: Yes. The information of neuropsychological tests, neuroimaging data are to be shared with other researchers.
Related trials for Gut Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Han, PhD principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplemented intervention in people with Gut Microbiota and Mild Cognitive Impairment, run by XuanwuH 2 at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Montreal cognitive assessment (MoCA) (time frame: Three months). The study lists 3 primary outcomes in all. 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 13 Jul 2022.