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Study of the Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Children with Refractory Asthma

Study of the Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Children with Refractory Asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065165
Enrollment
Unknown
Registered
2022-10-30
Start date
2022-11-10
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Refractory Asthma

Interventions

standard treatment group of asthma:Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide and Formoterol Fumarate Powder for Inhalatio
treatment group of standard and Omalizumab for Injection for asthma:Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide and Formot
treatment group of standard and Fecal Microbiota Transplantation for asthma:Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide an

Sponsors

Department of Pediatrics, Xijing Hospital, The Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: (1)Repeated wheezing, coughing, shortness of breath and chest tightness are mostly related to exposure to allergens, cold air, physical or chemical stimulation, respiratory tract infection, exercise and hyperventilation (such as laughter and crying), which often occur or worsen at night and/or in the morning. (2)During the attack, scattered or diffuse wheezing sounds can be heard in both lungs, mainly in the expiratory phase, and the expiratory phase is prolonged. (3)The above symptoms and signs were effectively or spontaneously relieved by anti asthma treatment. (4)Except wheezing, coughing, shortness of breath and chest tightness caused by other diseases. (5)Those with atypical clinical manifestations (such as no obvious wheezing or wheezing) should have at least one of the following: ? It is confirmed that there is reversible airflow restriction: a.Positive bronchodilation test: after 15 minutes of inhaled the quick results ß2 receptor agonists (such as salbutamol quantitative aerosol 200-400 µg), the Forced Expiratory Volume (FEV1) in the first second increased by = 12%; b.The pulmonary ventilation function improved after anti-inflammatory treatment: after 4 weeks of inhaled glucocorticoid and/or antileukotriene treatment, FEV1 increased by = 12%; ? Bronchial provocation test was positive; ? The mean value of maximum Peak Expiratory Flow (PEF) diurnal variation rate (continuous monitoring for 2 weeks) was = 13%. (6)Use includes inhalation of medium and high doses of glucocorticoids and long-term effects ß2 asthma that can not be well controlled after standard treatment of two or more kinds of agonists for at least 3-6 months. Those conforming to 1~4, 6 or 4-6 can be diagnosed as refractory asthma. The pulmonary ventilation function should be checked as far as possible to obtain the objective diagnostic basis of variable expiratory airflow restriction, avoid insufficient diagnosis or excessive diagnosis, and facilitate the long-term standardized control treatment of asthma.

Exclusion criteria

Exclusion criteria: (1)Aged over 14; (2)The children have fever, intestinal obstruction, intestinal bleeding, multiple organ failure, severe immunodeficiency disease and other diseases that may cause serious systemic reactions after Fecal Microbiota Transplantation; (3)Take antibiotics, non steroidal anti-inflammatory drugs(NSAIDs), microecological agents, gastric motility drugs, acid inhibitors and other drugs that affect intestinal flora 2 weeks before treatment; (4)Other moderate and severe respiratory diseases; (5)Accompanied with other serious diseases that may affect their survival (including serious infection, serious heart, kidney, respiratory, blood, endocrine, neuropsychiatric and other diseases) or combined with tumors.

Design outcomes

Primary

MeasureTime frame
Pulmonary function;Expiratory nitric oxide level;IL-4?IL-5?IL-10?IL-13?IL-17A?IFN-? and serum IgE;Number of eosinophils in blood;Composition, function and metabolites of intestinal and respiratory flora;

Countries

China

Contacts

Public ContactXin Sun

the First Affiliated Hospital of the Air Force Medical University

xinsun001@qq.com+86 13572536262

Outcome results

None listed

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