Study for clinical efficacy evaluation and mechanism of Chinese medicine in relieving antibiotic resistance and sensitizing resistant bacteria by taking drug-resistant bacterial diarrhea as an example

Phase 1

Conditions: Drug-resistant bacterial diarrhea in children

Registration Number: ITMCTR1900002803

Lead Sponsor: Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Aged 6 months to 14 years old;
2. In line with the diagnostic standards of traditional Chinese and western medicine, the course of the disease is less than 2 weeks, and the disease is mild and medium;
Diagnostic criteria of western medicine: refer to the 8th edition of Zhu futang Practical Pediatrics in 2015 and Clinical Practice Guide for Acute Infectious Diarrheal Disease in Chinese Children formulated by Digestive Group of Pediatrics Branch of Chinese Medical Association in 2016. If drug-resistant bacteria are found in fecal culture, it is drug-resistant bacterial diarrhea.Diagnostic criteria of Traditional Chinese Medicine: the relevant criteria for diarrhea, dampness and heat syndrome in children are formulated with reference to Pediatrics of Praditional Chinese Medicine, the 4th edition of the 13th Five-year New Century, 2016.
3. White blood cell count >=5 /HPF in routine test, accompanied by the determination of procalcitonin or CRP or the percentage of neutrophils is higher than normal;
4. Get the guardian's consent, fill in the informed consent form, and agree to participate in (children over 8 years old should sign the consent form).

Exclusion Criteria

1. Bacterial diarrhea caused by cholera, dysentery, typhoid and paratyphoid (white blood cell count in stool >=15 /HPF, a small number of red blood cells can be seen);
2. Severe dehydration, acidosis, shock, and immunodeficiency;
3. Patients with serious diseases of cardiovascular, liver, kidney and hematopoietic system and mental illness;
4. Acute diarrhea caused by intussusception and intestinal polyps;
5. Patients who underwent surgery within 30 days before the test and caused diarrhea;
6. Patients who failed to respond to treatment will be not included in this study;
7. Patients who participated in other clinical trials within 1 months;
8. Allergic constitution or be allergy to known components of the test drug.
Patients who meet any of the above criteria should be excluded.