Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition

NCT04861649 | Unknown

• 1 other identifier: FMT for COPD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fecal Microbiota Transplantation

Keywords

fecal microbiota transplantation, COPD, dystrophy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  6 months

• the changes of COPD

  The number of acute exacerbations in the previous year and the time of the last acute exacerbation

  6 months

Study Arms (1)

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)

Biological: fecal microbiota transplantation

Interventions

fecal microbiota transplantation BIOLOGICAL

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)

Effect and mechanism of fecal microbiota transplantation on patients with COPD malnutrition

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Asclepius Meditec Inc.: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Fecal Microbiota Transplantation

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Zeguang Zheng

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yimeng Xv

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• Peiyan Zhong

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• Ni Liu

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• Shixian Ye

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Zeguang Zheng

CONTACT

18928868242; zheng862080@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 27, 2021
• Study Start: March 9, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)