Fecal Microbiota TransplantationNCT04861649
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
A study testing fecal microbiota transplantation in people with Fecal Microbiota Transplantation, run by Shanghai Asclepius Meditec Inc. at 1 site in China.
Trial summary
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder. Its bacterial metabolites stimulate the parasympathetic nerve, regulate insulin secretion and other metabolic pathways of patients through neuroendocrine regulation, resulting in… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Fecal Microbiota Transplantation
- What is being tested?
- fecal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2021to 30 Dec 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD
- Tobacco use: current or former smokers with a continuous smoking history of more than 1 year.
- Subjects are willing and able to complete the follow-up according to the plan.
- Subjects can cooperate to complete relevant examination items.
- Compliance: Subjects must be willing to return to the hospital and complete all visits and evaluations according to the protocol.
Who cannot join
- Having a significant disease or condition other than COPD that, in the Investigator's judgment, would put the subject at risk for participating in the study or affect the study outcome and the subject's ability to participate in the study.
- Women who are pregnant or breastfeeding or who plan to become pregnant during the study period.
- Digestive system: ① patients with known gastrointestinal organic diseases.
- ② Complicated with intestinal double infection, such as Clostridium difficile infection, EHEC, Salmonella, Shigella, Campylobacter, plague and cytomegalovirus;
- ③ patients with various acute infections, tumors, severe arrhythmias, mental disorders, drug or alcohol addiction; (4) pregnant or lactating women; (5) Use of antibiotics or probiotics within the last 4 weeks; (6) There are taboo witnesses for this study; (7) Clinical investigators who were conducting other related COPD studies at the time of enrollment or within 3 months before enrollment;
- Complicated with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems.
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- Patients with lower back, chest and abdomen injuries or after surgery.
- People with mental disorder or cognitive impairment.
- Non-compliance: Subjects did not follow the study procedures, including non-compliance to complete the journal.
- Informed consent validity is in doubt: Subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study.
- Obesity (BMI≥28) Hyperlipidemia (1.5 times the upper limit of normal value of plasma total cholesterol > or 1.5 times the upper limit of normal value of triglyceride BBB>; Confirmed diabetic patients; Diagnosed cancer patients; Have used any antibiotics or antibiotics in the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fecal Microbiota Transplantation
Guangzhou, Guangdong
Lihao Wu
About this study
Official title: Metabonomics of Chronic Obstructive Pulmonary Disease and Fecal Microbial Transplantation in the Treatment of Malnutrition
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder. Its bacterial metabolites stimulate the parasympathetic nerve, regulate insulin secretion and other metabolic pathways of patients through neuroendocrine regulation, resulting in abnormal energy metabolism of lipids and sugars in the digestive tract, and finally lead to malnutrition.We hypothesized that fecal bacteria transplantation could reconstruct the normal intestinal flora, restore the intestinal digestion and absorption function of chronic obstructive pulmonary disease（COPD）patients and improve the state of malnutrition.
Read the detailed description
- improve the COPD patients with malnutrition is the key to improve the digestion and absorption function of chronic obstructive pulmonary disease (COPD) is one of the world's third most common cause of death, is characterized by progressive airflow limited, mainly by the long-term exposure to tobacco smoke and other harmful air pollutants. It has been reported that 20%-71% of COPD patients suffer from malnutrition, and there is a negative correlation between BMI and prognosis. There is increasing evidence that patients with COPD with lower BMI or fat-free mass index are associated with poorer prognosis and impaired long-term survival. At present, nutrition supplements are mainly used to solve the problem of COPD malnutrition, including vitamins and minerals, essential amino acids and biological amino acids, anti-inflammatory omega-3, high fat and high carbohydrate, etc., while the causes of COPD malnutrition and the relationship between COPD and metabolism have not been paid attention to. Although there is evidence that there is no malnutrition nutritional support can improve the prognosis of patients with COPD, but exist in patients with malnutrition, due to impaired digestion and absorption, increase nutrition supply, prone to patients with abdominal distension, vomiting, and diarrhea. Therefore, in order to improve malnutrition in patients with COPD, it is necessary to improve digestion and absorption function in patients with COPD.
- improve digestion and absorption function, first of all, correct the oxidative stress caused by intestinal flora disorder as part of the systemic oxidative stress response, copd patients with intestinal oxidative stress, oxidative stress result of active oxygen free radicals on colon epithelium mucosa layer of mucin, lead to the loss of protein, mucous layer thickness can be reduced to 50%, resulting in changes in the structure of intestinal tract; In addition, under the action of active oxygen free radicals, epithelial cells of the digestive tract, the close connection between protein oxidation lead to intestinal epithelial permeability enhancement, on the one hand, the intestinal toxins can after connection into the intestinal permeability increased cells, affect the digestion and absorption function of intestinal cells, on the other hand, the oxidative stress products into the lumen of blood, lead to bacterial flora disorder, further affect intestinal digestion and absorption of food. The common clinical manifestations of intestinal flora disorder are: mild abdominal distension, diarrhea, nausea, vomiting, water and electrolyte disturbance, hypoproteinemia, malnutrition, and even shock. Therefore, in order to improve intestinal digestion and absorption function, it is necessary to correct intestinal flora disorder caused by oxidative stress.
- intestinal flora and the relationship between nutrition, immunity, metabolism, neuroendocrine, normal human intestinal bacteria number, up to about 1013 ~ 1014 microbes, equivalent to 10 times of the total number of human tissue cells and its metabolites other tissue cells function to human body impact, the total number of genes at the same time, the intestinal bacteria coding is about more than 100 times of the total number of human genes, some experts believe that intestinal flora is one of the normal function of the human body organ, the abnormal organs, inevitably affects the health of human body.
Intestinal flora by helping to break down food and absorb nutrition, synthesis of nutrients, metabolites indirectly stimulate the nerve endocrine effects such as the host's nutritional status: promote ingested B vitamins (B3, B5, B6, B12) and other micronutrients, help absorb minerals (calcium, magnesium and iron, etc.), regulating metabolism of glucose and lipid storage.
Synthesis of micronutrients such as vitamin K, B12, biotin, folic acid and pantothenates; By affecting the integrity of mucosal epithelium, it plays an immune defense role.
Intestinal flora disturbance is related to the formation of metabolic diseases such as obesity and diabetes in the host. Rachels study showed that intestinal flora disturbance in rats can increase the production of acetate, and feeding acetate to rats can promote the secretion of insulin in rats, the mechanism of which is realized by the activation of acetate through the parasympathetic nerve.
The production of acetate increases, and the stimulation intensity of parasympathetic nerve is enhanced, which promotes insulin secretion, and promotes ghrelin secretion by consuming glucose and reducing hypoglycemia, leading to obesity.
A recent study also showed that the intestinal microbiome shifted from lean donors to patients with metabolic syndrome, resulting in increased insulin sensitivity of the receptors.4) animal models and patients with copd, there exist dysbacteriosis.
- Conditions
- Fecal Microbiota Transplantation
- Being tested
- fecal microbiota transplantation
- Keywords
- fecal microbiota transplantation, COPD, dystrophy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantationBiological
The nasointestinal tube was placed and the fecal bacteria of healthy people were transplanted with liquid fecal bacteria (three transplants per course of treatment).
200ml of bacterial liquid was transplanted for each course, containing 40g of bacterial volume, transplanted consecutively for 3 times, once a day)
| Study group | Role | What they receive |
|---|---|---|
| Effect and mechanism of fecal microbiota transplantation on patients with COPD malnutrition | Experimental | During COPD stable period, nasal and intestinal tubes were placed and fecal bacteria were transplanted from healthy people (three transplants per course of treatment).
200ml of bacterial liquid was transplanted for each course, containing 40g of bacterial volume, transplanted consecutively for 3 times, once a day) Receives: Biological: fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of intestinal flora in COPD malnutrition subjects during the whole 6 months
The changes of intestinal flora were detected by 16SrDNA technology during the 6 months.
Measured: 6 months
Nutritional indicators in COPD malnutrition subjects during the whole 6 months
including prealbumin, nutritional risk screening 2002 and scored patient-generated subjective global assessment.
Measured: 6 months
the changes of COPD
The number of acute exacerbations in the previous year and the time of the last acute exacerbation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start9 Mar 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Asclepius Meditec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeguang Zheng, Principal investigator, The First Affiliated Hospital of Guangzhou Medical UniversityYimeng Xv, Study chair, The First Affiliated Hospital of Guangzhou Medical UniversityPeiyan Zhong, Study chair, The First Affiliated Hospital of Guangzhou Medical UniversityNi Liu, Study chair, The First Affiliated Hospital of Guangzhou Medical UniversityShixian Ye, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861649
- Sponsor's protocol ID
- FMT for COPD
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabonomics of Chronic Obstructive Pulmonary Disease and Fecal Microbial Transplantation in the Treatment of Malnutrition
- ClinicalTrials.gov ID
- NCT04861649
- Acronym / sponsor ID
- FMT for COPD
- Conditions
- Fecal Microbiota Transplantation
- Keywords
- fecal microbiota transplantation, COPD, dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Asclepius Meditec Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Apr 2021 (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.
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder. Its bacterial metabolites stimulate the parasympathetic nerve, regulate insulin secretion and other metabolic pathways of patients through neuroendocrine regulation, resulting in abnormal energy metabolism of lipids and sugars in the digestive tract, and finally lead to malnutrition.We hypothesized that fecal bacteria transplantation could reconstruct the normal intestinal flora, restore the intestinal digestion and absorption function of chronic obstructive pulmonary disease（COPD）patients and improve the state of malnutrition.
Detailed description
- improve the COPD patients with malnutrition is the key to improve the digestion and absorption function of chronic obstructive pulmonary disease (COPD) is one of the world's third most common cause of death, is characterized by progressive airflow limited, mainly by the long-term exposure to tobacco smoke and other harmful air pollutants. It has been reported that 20%-71% of COPD patients suffer from malnutrition, and there is a negative correlation between BMI and prognosis. There is increasing evidence that patients with COPD with lower BMI or fat-free mass index are associated with poorer prognosis and impaired long-term survival. At present, nutrition supplements are mainly used to solve the problem of COPD malnutrition, including vitamins and minerals, essential amino acids and biological amino acids, anti-inflammatory omega-3, high fat and high carbohydrate, etc., while the causes of COPD malnutrition and the relationship between COPD and metabolism have not been paid attention to. Although there is evidence that there is no malnutrition nutritional support can improve the prognosis of patients with COPD, but exist in patients with malnutrition, due to impaired digestion and absorption, increase nutrition supply, prone to patients with abdominal distension, vomiting, and diarrhea. Therefore, in order to improve malnutrition in patients with COPD, it is necessary to improve digestion and absorption function in patients with COPD.
- improve digestion and absorption function, first of all, correct the oxidative stress caused by intestinal flora disorder as part of the systemic oxidative stress response, copd patients with intestinal oxidative stress, oxidative stress result of active oxygen free radicals on colon epithelium mucosa layer of mucin, lead to the loss of protein, mucous layer thickness can be reduced to 50%, resulting in changes in the structure of intestinal tract; In addition, under the action of active oxygen free radicals, epithelial cells of the digestive tract, the close connection between protein oxidation lead to intestinal epithelial permeability enhancement, on the one hand, the intestinal toxins can after connection into the intestinal permeability increased cells, affect the digestion and absorption function of intestinal cells, on the other hand, the oxidative stress products into the lumen of blood, lead to bacterial flora disorder, further affect intestinal digestion and absorption of food. The common clinical manifestations of intestinal flora disorder are: mild abdominal distension, diarrhea, nausea, vomiting, water and electrolyte disturbance, hypoproteinemia, malnutrition, and even shock. Therefore, in order to improve intestinal digestion and absorption function, it is necessary to correct intestinal flora disorder caused by oxidative stress.
- intestinal flora and the relationship between nutrition, immunity, metabolism, neuroendocrine, normal human intestinal bacteria number, up to about 1013 ~ 1014 microbes, equivalent to 10 times of the total number of human tissue cells and its metabolites other tissue cells function to human body impact, the total number of genes at the same time, the intestinal bacteria coding is about more than 100 times of the total number of human genes, some experts believe that intestinal flora is one of the normal function of the human body organ, the abnormal organs, inevitably affects the health of human body.
Intestinal flora by helping to break down food and absorb nutrition, synthesis of nutrients, metabolites indirectly stimulate the nerve endocrine effects such as the host's nutritional status: promote ingested B vitamins (B3, B5, B6, B12) and other micronutrients, help absorb minerals (calcium, magnesium and iron, etc.), regulating metabolism of glucose and lipid storage.
Synthesis of micronutrients such as vitamin K, B12, biotin, folic acid and pantothenates; By affecting the integrity of mucosal epithelium, it plays an immune defense role.
Intestinal flora disturbance is related to the formation of metabolic diseases such as obesity and diabetes in the host. Rachels study showed that intestinal flora disturbance in rats can increase the production of acetate, and feeding acetate to rats can promote the secretion of insulin in rats, the mechanism of which is realized by the activation of acetate through the parasympathetic nerve.
The production of acetate increases, and the stimulation intensity of parasympathetic nerve is enhanced, which promotes insulin secretion, and promotes ghrelin secretion by consuming glucose and reducing hypoglycemia, leading to obesity.
A recent study also showed that the intestinal microbiome shifted from lean donors to patients with metabolic syndrome, resulting in increased insulin sensitivity of the receptors.4) animal models and patients with copd, there exist dysbacteriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect and mechanism of fecal microbiota transplantation on patients with COPD malnutrition | Experimental | Biological: fecal microbiota transplantationDuring COPD stable period, nasal and intestinal tubes were placed and fecal bacteria were transplanted from healthy people (three transplants per course of treatment). 200ml of bacterial liquid was transplanted for each course, containing 40g of bacterial volume, transplanted consecutively for 3 times, once a day) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of COPD
- Tobacco use: current or former smokers with a continuous smoking history of more than 1 year.
- Subjects are willing and able to complete the follow-up according to the plan.
- Subjects can cooperate to complete relevant examination items.
- Compliance: Subjects must be willing to return to the hospital and complete all visits and evaluations according to the protocol.
Key exclusion criteria (11 listed)
- Having a significant disease or condition other than COPD that, in the Investigator's judgment, would put the subject at risk for participating in the study or affect the study outcome and the subject's ability to participate in the study.
- Women who are pregnant or breastfeeding or who plan to become pregnant during the study period.
- Digestive system: ① patients with known gastrointestinal organic diseases.
- ② Complicated with intestinal double infection, such as Clostridium difficile infection, EHEC, Salmonella, Shigella, Campylobacter, plague and cytomegalovirus;
- ③ patients with various acute infections, tumors, severe arrhythmias, mental disorders, drug or alcohol addiction; (4) pregnant or lactating women; (5) Use of antibiotics or probiotics within the last 4 weeks; (6) There are taboo witnesses for this study; (7) Clinical investigators who were conducting other related COPD studies at the time of enrollment or within 3 months before enrollment;
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 |
|---|---|---|
| fecal microbiota transplantationThe nasointestinal tube was placed and the fecal bacteria of healthy people were transplanted with liquid fecal bacteria (three transplants per course of treatment). 200ml of bacterial liquid was transplanted for each course, containing 40g of bacterial volume, transplanted consecutively for 3 times, once a day) | Biological | Effect and mechanism of fecal microbiota transplantation on patients with COPD malnutrition |
Primary outcome
Changes of intestinal flora in COPD malnutrition subjects during the whole 6 months
Time frame: 6 months
The changes of intestinal flora were detected by 16SrDNA technology during the 6 months.
Nutritional indicators in COPD malnutrition subjects during the whole 6 months
Time frame: 6 months
including prealbumin, nutritional risk screening 2002 and scored patient-generated subjective global assessment.
the changes of COPD
Time frame: 6 months
The number of acute exacerbations in the previous year and the time of the last acute exacerbation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Yes. the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
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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.
Zeguang Zheng principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Yimeng Xv study chair
The First Affiliated Hospital of Guangzhou Medical University
Peiyan Zhong study chair
The First Affiliated Hospital of Guangzhou 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 fecal microbiota transplantation in people with Fecal Microbiota Transplantation, run by Shanghai Asclepius Meditec Inc. 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 11 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: status not confirmed, as of the sponsor's last update on 27 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeguang Zheng (18928868242, zheng862080@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of intestinal flora in COPD malnutrition subjects during the whole 6 months (time frame: 6 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 27 Apr 2021.