Clinical trial NCT04702542: To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Official title: To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology (CGDP) in Schoolchildren in the Primary Health Care System.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastritis Chronic
Gastroduodenitis
Peptic Ulcer
Duodenal Ulcer
Keywords: children
duodenal ulcer
gastritis
gastroduodenitis
Helicobacter pylori
oxygen therapy
rehabilitation
peptic ulcer
teenagers
Lead sponsor: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of 2 mutually comparable patient groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: In recent years, among the non-infectious diseases of children and adolescents, there has been an increase in many nosological forms of pathology of the gastrointestinal tract. Scientific works of recent years show that all over the world much attention is paid to the problem of timely prevention and improvement of chronic diseases of the gastroduodenal zone in children. This is mainly due to the fact that the incidence of diseases of the digestive system among schoolchildren is steadily increasing. In the clinical practice of gastroenterologists, it is often necessary to influence the regeneration processes in the gastroduodenal zone. 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.

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.

Primary outcomes:
measure: Initial clinical examination of children and adolescents at risk of CGDP.
timeFrame: 2 weeks
measure: Identification of Helicobacter pylori infection.
timeFrame: 2 weeks
measure: Esofibrogastroduodenoscopy at the start of the study
timeFrame: 2 weeks
measure: Treatment of identified patients.
timeFrame: 6 weeks
measure: Rehabilitation of patients using enteral oxygen therapy.
timeFrame: 6 weeks
measure: Esofibrogastroduodenoscopy after rehabilitation.
timeFrame: 2 weeks
Secondary outcomes:
measure: Statistical data processing.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Tashkent Pediatric Medical Institute
Study officials:
affiliation: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
name: Shokhida Turdieva, MD
role: STUDY_DIRECTOR
References: