Clinical trial
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology (CGDP) in Schoolchildren in the Primary Health Care System.
Name
TashkentPediatricMI-2
Description
The object of the study will be children and adolescents from 6 to 15 years old, living in the city of Tashkent and in the Tashkent region. We will study patients with various clinical forms of chronic gastroduodenal pathology (CGDP). The effect of enteral oxygen therapy in the recovery of patients with CGDP due to the positive effect of the active form of oxygen on the hematological system and on the regenerative processes in the gastrointestinal tract will be studied. At the same time, the effect of enteral oxygen therapy on enhancing the effectiveness of eradication therapy during the treatment of carrier Helicobacter pylori due to the neutralization of the products of urea hydrolysis around bacteria under the action of reactive oxygen species will be studied.
Trial arms
Trial start
2020-01-04
Estimated PCD
2025-12-30
Trial end
2028-12-30
Status
Active (not recruiting)
Treatment
Enteral oxygen therapy
Enteral oxygen therapy during the rehabilitation period of patients with CGDP.
Arms:
Enteral oxygen therapy for the improvement of children with chronic gastroduodenal pathology.
Other names:
Standard recreational activities for children after inpatient treatment.
Size
320
Primary endpoint
Initial clinical examination of children and adolescents at risk of CGDP.
2 weeks
Identification of Helicobacter pylori infection.
2 weeks
Esofibrogastroduodenoscopy at the start of the study
2 weeks
Treatment of identified patients.
6 weeks
Rehabilitation of patients using enteral oxygen therapy.
6 weeks
Esofibrogastroduodenoscopy after rehabilitation.
2 weeks
Eligibility criteria
Inclusion Criteria:
* children and adolescents aged 6 to 15 years;
* children with chronic gastroduodenal pathology: chronic gastritis, chronic gastroduodenitis, chronic duodenitis, gastric and intestinal ulcers of both sexes;
* children who have the opportunity to visit the clinic.
Exclusion Criteria:
* children under 6 years old and adolescents over 15 years old;
* children with chronic diseases of internal organs, except for the gastrointestinal tract;
* children with psychosomatic and neurological disorders;
* children in hospital;
* children with endocrine diseases;
* children who are allergic to eggs;
* children with blood diseases;
* children with cancer.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Comparison of 2 mutually comparable patient groups.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 320, 'type': 'ESTIMATED'}}
Updated at
2023-12-21
1 organization
1 product
3 indications
Organization
Tashkent Pediatric Medical InstituteProduct
Enteral oxygen therapyIndication
GastritisIndication
GastroduodenitisIndication
Peptic Ulcer