Intestinal MicrobiotaNCT03401736
The Diversity of Intestinal Microbiota in Patients With Different Sedative-hypnotics Undergoing Mechanical Ventilation
A study testing Mechanical Ventilation, Midazolam and Dexmedetomidine in people with Intestinal Microbiota and Mechanical Ventilation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Microbiota, Mechanical Ventilation
- What is being tested?
- Mechanical Ventilation, Midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who receive long-term (≥12 hours) mechanical ventilation after operation on admission to the ICU
- APACHEII score 12-20 points
- no receive other clinical trials in the near 3 months
- no acute infectious disease, psychosis or other disease
- volunteer people
Who cannot join
- known or suspected allergy to midazolam or Dexmedetomidine
- suspected pregnancy, gross obesity, hyperlipemia, moribund state
- history of alcoholism or intake of anti-anxiety drugs or hypnotics
- chronic renal failure
- coma by cranial trauma or neurosurgery or unknown etiology or status epilepticus
- unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Relationship Between Biodiversity of Intestinal Microbiota in Patients and Different Sedative-hypnotics Undergoing Mechanical Ventilation
Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far，whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile，the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.
Read the detailed description
There are a variety of normal microbial communities in the healthy human intestines, which maintain the physiological balance of the host. Under normal circumstances, there are about 104 intestinal microflora in the adult's intestines. The total number of genes is about 150 times the number of human genes. More and more studies have found that intestinal flora plays an important role in the occurrence of many human diseases. In recent years, the role of intestinal microflora in the brain axis has gradually been recognized and become a hot spot of research, and a new concept of the brain - gut axis is proposed.
The brain-gut axis is a bidirectional communication system between the central nervous system (CNS) and the gastrointestinal tract. Compared with ordinary mice, mild exposure to pressure can increase the level of corticosterone and adrenocorticotropic hormone in sterile mice, and this overreaction can be reversed by transplantation of normal rats' feces.Together, it is clear that the gut microbiota can be a key regulator of mood, cognition, pain, and obesity. Understanding microbiota-brain interactions is an exciting area of research which may contribute new insights into individual variations in cognition, personality, mood, sleep, and eating behavior.The abnormal expression of GABA (GABA) receptor in central nervous system is related to anxiety and depression. It is found that probiotics can regulate the expression of GABA receptor in the cerebral cortex through vagus nerve, thereby reducing anxiety and depression.5-HT signal system abnormalities may be associated with the pathophysiological changes of irritable bowel syndrome (IBS), while intestinal flora can affect the generation of neurotransmitter 5-HT in the intestine, resulting in changing of gastrointestinal motility and sensibility of internal organ. The above study means that the brain axis plays an important role in maintaining the diversity of intestinal microbiota.
It is essential that using sedatives to maintain the safety and comfort of the patient in ICU.Most patients also need receiving mechanical ventilation.Many patients in Intensive care unit appear varying degrees of intestinal microflora imbalance,especially received mechanical ventilation.So far,whether sedatives used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not still not been reported. The effects of different sedative drugs on the intestinal flora diversity also need further study.Therefore, the topic will discuss the diversity of intestinal microbiota in patients with different sedative-hypnotics and mechanical ventilation.
- Conditions
- Intestinal Microbiota, Mechanical Ventilation
- Being tested
- Mechanical Ventilation, Midazolam, Dexmedetomidine
- Keywords
- Sedatives and Hypnotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationDevice
Whether midazolam and dexmedetomidine have an effect on the diversity of intestinal microbiota or not is still unknown，especially the patient who requires the mechanical ventilation.
MidazolamDrug
Also called Midazolam injection
The impact of Midazolam on the diversity of intestinal microbiota.
DexmedetomidineDrug
Also called Dexmedetomidine injection
The impact of dexmedetomidine on the diversity of intestinal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Group M：received midazolam | Experimental | Patients who requires the mechanical ventilation allocated to the midazolam group (group M) were treated with an infusion bolus of 0.05 mg/kg and continuous infusion of 0.04 to 0.20 mg/kg/hour, with the dosage adjusted to achieve the desired level of sedation. Receives: Device: Mechanical Ventilation; Drug: Midazolam |
| Group D: received dexmedetomidine | Active comparator | Patients who requires the mechanical ventilation allocated to the dexmedetomidine group (group D) received an infusion bolus of 1 ug/kg within 10 minutes and continuous infusion of 0.25 to 0.75 ug/kg/hour, with the dosage adjusted to achieve the desired level of sedation.All patients maintained BIS between 65~85 and the Ramsay score was 3 to 4. Receives: Device: Mechanical Ventilation; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changing trends of the diversity of Intestinal microbiota
Bacterial diversity revealed by 16S ribosomal RNA (rRNA) gene high-throughput sequencing (HTS).Feces were collected before operation from patients who had surgery.After the first collection, another was collected when the patient received mechanical ventilation more than 12 hours.
Measured: Up to 1 year from the beginning of the study
Secondary outcomes (3)
The changing trends of weight
The changing trends of weight was recorded in kilograms by the experimental assistant
Measured: Up to 1 month from the beginning of the study
duration of sedation
BIS and Ramsay score were described by the anesthetist physician
Measured: Time from achieving sedation until reaching full consciousness,up to 1 week.
Duration of mechanical ventilation
Duration of mechanical ventilation was described by the anesthetist physician
Measured: Up to 3 days from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Oct 2020
- Study completion1 Nov 2020
Why it stopped: Can't get enough participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intestinal MicrobiotaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Li Jing Jie, M.D., Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401736
- Sponsor's protocol ID
- 2017-443-T339
- Status last verified
- Sep 2021
- First submitted
- 16 Dec 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulak A, Bonaz B. Brain-gut-microbiota axis in Parkinson's disease. World J Gastroenterol. 2015 Oct 7;21(37):10609-20. doi: 10.3748/wjg.v21.i37.10609.
PubMed 26457021Evrensel A, Ceylan ME. Fecal Microbiota Transplantation and Its Usage in Neuropsychiatric Disorders. Clin Psychopharmacol Neurosci. 2016 Aug 31;14(3):231-7. doi: 10.9758/cpn.2016.14.3.231.
PubMed 27489376Al Omran Y, Aziz Q. The brain-gut axis in health and disease. Adv Exp Med Biol. 2014;817:135-53. doi: 10.1007/978-1-4939-0897-4_6.
PubMed 24997032Luna RA, Savidge TC, Williams KC. The Brain-Gut-Microbiome Axis: What Role Does It Play in Autism Spectrum Disorder? Curr Dev Disord Rep. 2016 Mar;3(1):75-81. doi: 10.1007/s40474-016-0077-7. Epub 2016 Feb 26.
PubMed 27398286Mayer EA, Padua D, Tillisch K. Altered brain-gut axis in autism: comorbidity or causative mechanisms? Bioessays. 2014 Oct;36(10):933-9. doi: 10.1002/bies.201400075. Epub 2014 Aug 22.
PubMed 25145752Li Q, Zhou JM. The microbiota-gut-brain axis and its potential therapeutic role in autism spectrum disorder. Neuroscience. 2016 Jun 2;324:131-9. doi: 10.1016/j.neuroscience.2016.03.013. Epub 2016 Mar 8.
PubMed 26964681van De Sande MM, van Buul VJ, Brouns FJ. Autism and nutrition: the role of the gut-brain axis. Nutr Res Rev. 2014 Dec;27(2):199-214. doi: 10.1017/S0954422414000110. Epub 2014 Jul 8.
PubMed 25004237Atkinson W, Lockhart S, Whorwell PJ, Keevil B, Houghton LA. Altered 5-hydroxytryptamine signaling in patients with constipation- and diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2006 Jan;130(1):34-43. doi: 10.1053/j.gastro.2005.09.031.
PubMed 16401466Dizdar V, Spiller R, Singh G, Hanevik K, Gilja OH, El-Salhy M, Hausken T. Relative importance of abnormalities of CCK and 5-HT (serotonin) in Giardia-induced post-infectious irritable bowel syndrome and functional dyspepsia. Aliment Pharmacol Ther. 2010 Apr;31(8):883-91. doi: 10.1111/j.1365-2036.2010.04251.x. Epub 2010 Feb 2.
PubMed 20132151
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Relationship Between Biodiversity of Intestinal Microbiota in Patients and Different Sedative-hypnotics Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03401736
- Acronym / sponsor ID
- 2017-443-T339
- Conditions
- Intestinal Microbiota, Mechanical Ventilation
- Keywords
- Sedatives and Hypnotics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Can't get enough participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 17 Jan 2018 (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.
Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far，whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile，the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.
Detailed description
There are a variety of normal microbial communities in the healthy human intestines, which maintain the physiological balance of the host. Under normal circumstances, there are about 104 intestinal microflora in the adult's intestines. The total number of genes is about 150 times the number of human genes. More and more studies have found that intestinal flora plays an important role in the occurrence of many human diseases. In recent years, the role of intestinal microflora in the brain axis has gradually been recognized and become a hot spot of research, and a new concept of the brain - gut axis is proposed.
The brain-gut axis is a bidirectional communication system between the central nervous system (CNS) and the gastrointestinal tract. Compared with ordinary mice, mild exposure to pressure can increase the level of corticosterone and adrenocorticotropic hormone in sterile mice, and this overreaction can be reversed by transplantation of normal rats' feces.Together, it is clear that the gut microbiota can be a key regulator of mood, cognition, pain, and obesity. Understanding microbiota-brain interactions is an exciting area of research which may contribute new insights into individual variations in cognition, personality, mood, sleep, and eating behavior.The abnormal expression of GABA (GABA) receptor in central nervous system is related to anxiety and depression. It is found that probiotics can regulate the expression of GABA receptor in the cerebral cortex through vagus nerve, thereby reducing anxiety and depression.5-HT signal system abnormalities may be associated with the pathophysiological changes of irritable bowel syndrome (IBS), while intestinal flora can affect the generation of neurotransmitter 5-HT in the intestine, resulting in changing of gastrointestinal motility and sensibility of internal organ. The above study means that the brain axis plays an important role in maintaining the diversity of intestinal microbiota.
It is essential that using sedatives to maintain the safety and comfort of the patient in ICU.Most patients also need receiving mechanical ventilation.Many patients in Intensive care unit appear varying degrees of intestinal microflora imbalance,especially received mechanical ventilation.So far,whether sedatives used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not still not been reported. The effects of different sedative drugs on the intestinal flora diversity also need further study.Therefore, the topic will discuss the diversity of intestinal microbiota in patients with different sedative-hypnotics and mechanical ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M：received midazolam | Experimental | Device: Mechanical Ventilation, Drug: MidazolamPatients who requires the mechanical ventilation allocated to the midazolam group (group M) were treated with an infusion bolus of 0.05 mg/kg and continuous infusion of 0.04 to 0.20 mg/kg/hour, with the dosage adjusted to achieve the desired level of sedation. |
| Group D: received dexmedetomidine | Active comparator | Device: Mechanical Ventilation, Drug: DexmedetomidinePatients who requires the mechanical ventilation allocated to the dexmedetomidine group (group D) received an infusion bolus of 1 ug/kg within 10 minutes and continuous infusion of 0.25 to 0.75 ug/kg/hour, with the dosage adjusted to achieve the desired level of sedation.All patients maintained BIS between 65~85 and the Ramsay score was 3 to 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients who receive long-term (≥12 hours) mechanical ventilation after operation on admission to the ICU
- APACHEII score 12-20 points
- no receive other clinical trials in the near 3 months
- no acute infectious disease, psychosis or other disease
- volunteer people
Key exclusion criteria (6 listed)
- known or suspected allergy to midazolam or Dexmedetomidine
- suspected pregnancy, gross obesity, hyperlipemia, moribund state
- history of alcoholism or intake of anti-anxiety drugs or hypnotics
- chronic renal failure
- coma by cranial trauma or neurosurgery or unknown etiology or status epilepticus
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 |
|---|---|---|
| Mechanical VentilationWhether midazolam and dexmedetomidine have an effect on the diversity of intestinal microbiota or not is still unknown，especially the patient who requires the mechanical ventilation. | Device | Group D: received dexmedetomidine, Group M：received midazolam |
| MidazolamAlso: Midazolam injectionThe impact of Midazolam on the diversity of intestinal microbiota. | Drug | Group M：received midazolam |
| DexmedetomidineAlso: Dexmedetomidine injectionThe impact of dexmedetomidine on the diversity of intestinal microbiota. | Drug | Group D: received dexmedetomidine |
Primary outcome
The changing trends of the diversity of Intestinal microbiota
Time frame: Up to 1 year from the beginning of the study
Bacterial diversity revealed by 16S ribosomal RNA (rRNA) gene high-throughput sequencing (HTS).Feces were collected before operation from patients who had surgery.After the first collection, another was collected when the patient received mechanical ventilation more than 12 hours.
3 secondary outcomes
The changing trends of weight
Time frame: Up to 1 month from the beginning of the study
duration of sedation
Time frame: Time from achieving sedation until reaching full consciousness,up to 1 week.
Duration of mechanical ventilation
Time frame: Up to 3 days from the beginning of the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 26457021Mulak A, Bonaz B. Brain-gut-microbiota axis in Parkinson's disease. World J Gastroenterol. 2015 Oct 7;21(37):10609-20. doi: 10.3748/wjg.v21.i37.10609.
- Background: PubMed 27489376Evrensel A, Ceylan ME. Fecal Microbiota Transplantation and Its Usage in Neuropsychiatric Disorders. Clin Psychopharmacol Neurosci. 2016 Aug 31;14(3):231-7. doi: 10.9758/cpn.2016.14.3.231.
- Background: PubMed 24997032Al Omran Y, Aziz Q. The brain-gut axis in health and disease. Adv Exp Med Biol. 2014;817:135-53. doi: 10.1007/978-1-4939-0897-4_6.
- Background: PubMed 27398286Luna RA, Savidge TC, Williams KC. The Brain-Gut-Microbiome Axis: What Role Does It Play in Autism Spectrum Disorder? Curr Dev Disord Rep. 2016 Mar;3(1):75-81. doi: 10.1007/s40474-016-0077-7. Epub 2016 Feb 26.
- Background: PubMed 25145752Mayer EA, Padua D, Tillisch K. Altered brain-gut axis in autism: comorbidity or causative mechanisms? Bioessays. 2014 Oct;36(10):933-9. doi: 10.1002/bies.201400075. Epub 2014 Aug 22.
- Background: PubMed 26964681Li Q, Zhou JM. The microbiota-gut-brain axis and its potential therapeutic role in autism spectrum disorder. Neuroscience. 2016 Jun 2;324:131-9. doi: 10.1016/j.neuroscience.2016.03.013. Epub 2016 Mar 8.
- Background: PubMed 25004237van De Sande MM, van Buul VJ, Brouns FJ. Autism and nutrition: the role of the gut-brain axis. Nutr Res Rev. 2014 Dec;27(2):199-214. doi: 10.1017/S0954422414000110. Epub 2014 Jul 8.
- Background: PubMed 16401466Atkinson W, Lockhart S, Whorwell PJ, Keevil B, Houghton LA. Altered 5-hydroxytryptamine signaling in patients with constipation- and diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2006 Jan;130(1):34-43. doi: 10.1053/j.gastro.2005.09.031.
- Background: PubMed 20132151Dizdar V, Spiller R, Singh G, Hanevik K, Gilja OH, El-Salhy M, Hausken T. Relative importance of abnormalities of CCK and 5-HT (serotonin) in Giardia-induced post-infectious irritable bowel syndrome and functional dyspepsia. Aliment Pharmacol Ther. 2010 Apr;31(8):883-91. doi: 10.1111/j.1365-2036.2010.04251.x. Epub 2010 Feb 2.
- Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Li Jing Jie, M.D. study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 Mechanical Ventilation, Midazolam and Dexmedetomidine in people with Intestinal Microbiota and Mechanical Ventilation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 5 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: withdrawn, as of the sponsor's last update on 28 Sep 2021. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
The changing trends of the diversity of Intestinal microbiota (time frame: Up to 1 year from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401736, which also lists 9 linked publications.
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 28 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.