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Study on metabonomics and fecal-microbiota transplantation to improve nutrition and prognosis in convalescent stage of severe pneumonia

Study on metabonomics and fecal-microbiota transplantation to improve nutrition and prognosis in convalescent stage of severe pneumonia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053312
Enrollment
Unknown
Registered
2021-11-18
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe pneumonia

Interventions

FMT group:Fecal-microbiota transplantation (FMT)

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign a written informed consent; 2. Female subjects must meet the following conditions to participate in the study: no potential fertility (that is, physiologically incapable of pregnancy, including women who have been menopausal for 2 years) or no pregnancy plan; 3. Severe pneumonia was diagnosed in the past month: based on the definition of the guidelines for the diagnosis and treatment of adult community-acquired pneumonia developed by the Respiratory Branch of Chinese Medical Association in 2016, the characteristics are as follows: (1) Main criteria: invasive mechanical ventilation; vasoactive drugs are still needed after active humoral resuscitation in septic shock; (2) Secondary criteria: respiratory rate > 30 beats/min; PaO2/FiO2 = 7 mmol/min; systolic blood pressure = 12 mmHg or at least 4 times a day is not lower than 12 mmHg); (3) Abdominal compartment syndrome (ACS): intra-abdominal pressure >= 20 mmHg and new organ dysfunction occurred at least twice in 6 hours; (4) Gastric retention: a single gastric juice withdrawal exceeding 200 ml is defined as massive gastric retention; (5) Diarrhea: more than three times a day dilute stool, and the amount is greater than 200~250 g/d (or more than 250 ml/d); (6) Vomiting fluid, stomach contents or feces and other samples occult blood test positive; (7) Lower gastrointestinal paralysis (paralytic intestinal obstruction): finger intestinal peristalsis function is impaired, resulting in feces can not be excreted from the body. Clinical symptoms include at least 3 days of anal cessation of defecation, the presence or disappearance of bowel sounds, and the need to rule out mechanical intestinal obstruction; 6. The subjects are willing and able to complete the follow-up according to the plan; 7. The subjects can cooperate to complete the relevant inspection items; 8. Compliance: subjects must be willing to return to hospital for follow-up according to the plan and complete all visit assessments.

Exclusion criteria

Exclusion criteria: 1. Critically ill patients with early resuscitation, hemodynamic instability and severe water-electrolyte acid-base imbalance; 2. Digestive system: (1) Patients with known gastrointestinal organic diseases; (2) Double infection with intestinal tract, such as Clostridium labile infection, Enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, Yersinia pestis and Cytomegalovirus, etc.; (3) Various acute infections, tumors, severe arrhythmias, mental system diseases, drug or alcohol addiction; (4) Massive gastrointestinal bleeding; (5) Contraindications to this study; (6) Other clinical researchers were being carried out at the time of joining the group or within 3 months before joining the group; 3. Severe primary diseases of important organs or systems such as heart, liver, kidney and hematopoietic system were complicated; 4. Patients with waist and back, chest and abdomen injury or after operation; 5. People with mental abnormality and cognitive impairment; 6. There are doubts about the validity of informed consent: subjects with a history of mental illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other diseases that restrict the effectiveness of informed consent in this study.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;Plasma metabolomics;

Secondary

MeasureTime frame
Inflammation indicators;Intestinal barrier function;

Countries

China

Contacts

Public ContactZheng Zeguang

Guangzhou Medical University

zheng862080@139.com+86 18928868242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026