To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.

NCT ID: NCT04702542

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2028-12-30

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.

Conditions

Gastritis Chronic; Gastroduodenitis; Peptic Ulcer; Duodenal Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enteral oxygen therapy for the improvement of children with chronic gastroduodenal pathology.

Enteral oxygen therapy is prescribed for children with chronic gastroduodenal pathology during the recovery period, after inpatient treatment, for 14 days, every day, in the form of an oxygen cocktail. An oxygen cocktail is prepared on the basis of a pharmaceutical product using herbal ingredients. The patient takes a 200 ml oxygen cocktail. using a small spoon, during the daytime.

Group Type: EXPERIMENTAL

Enteral oxygen therapy

Intervention Type: DRUG

Enteral oxygen therapy during the rehabilitation period of patients with CGDP.

Interventions

Enteral oxygen therapy

Enteral oxygen therapy during the rehabilitation period of patients with CGDP.

Intervention Type: DRUG

Other Intervention Names

Standard recreational activities for children after inpatient treatment.

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

OTHER

Sponsor Role: lead

Responsible Party

Turdieva Shokhida Tolkunovna, MD

МD, associate professor of the Department "Outpatient care"

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shokhida Turdieva, MD

Role: STUDY_DIRECTOR

Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Locations

Tashkent Pediatric Medical Institute

Tashkent, , Uzbekistan

Countries

Uzbekistan

Other Identifiers

TashkentPediatricMI-2

Identifier Type: -

Identifier Source: org_study_id