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

NCT04702542 | Active Not Recruiting DMC

• 1 other identifier: TashkentPediatricMI-2
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastritis Chronic; Gastroduodenitis; Peptic Ulcer; Duodenal Ulcer

Keywords

children; duodenal ulcer; gastritis; gastroduodenitis; Helicobacter pylori; oxygen therapy; rehabilitation; peptic ulcer; teenagers

Outcome Measures

Primary Outcomes (6)

• Initial clinical examination of children and adolescents at risk of CGDP.

  A clinical examination of patients will be carried out, consisting of: identification of complaints - epigastric pain, dyspeptic symptoms - vomiting, panos, constipation, loss of appetite (oral questioning based on standard questions and scale HBSC (Health Behaviour in School-aged Children, A.King, 1996); collection of data on the presence in the family of a patient with this disease (oral survey based on standard questions); general examination of the patient - the presence of abdominal pain syndrome, stiffness of the abdominal muscles, intestinal distention (palpation, percussion, auscultation).

  2 weeks

• Identification of Helicobacter pylori infection.

  The study for Helicobacter pylori (HP) infection will be based on the qualitative determination of the pathogen by two mutually unrelated methods: using a breath test (HELIK® test system with an indicator tube) and an immunochromatographic fecal sample for the presence of occult blood (erythrocyte cells).The interpretation of the test is either "positive" or "negative". The patient will be considered HP infected if both tests are positive.

  2 weeks

• Esofibrogastroduodenoscopy at the start of the study

  Esofibrogastroduodenoscopy is carried out with an assessment of the endoscopic picture of the visible mucous membranes of the stomach and duodenum according to the criteria of the generally accepted Sydney classification (1990, with a modification of 1996), with a description of the visible mucous organ: the presence of areas of hyperemia, ulcers, atrophy, hypertrophy, scarring (visual description).

  2 weeks

• Treatment of identified patients.

  If a disease is detected, the patient will be referred for treatment to a specialized children's hospital (Tashkent), where he will receive appropriate treatment according to generally accepted standards. The effectiveness of treatment will be assessed by the manifestation of clinical symptoms: the presence of complaints - epigastric pain, dyspeptic symptoms - vomiting, panos, constipation, loss of appetite (oral questioning based on standard questions); general examination of the patient - the presence of abdominal pain syndrome, stiffness of the abdominal muscles, intestinal distention (palpation, percussion, auscultation).

  6 weeks

• Rehabilitation of patients using enteral oxygen therapy.

  Rehabilitation of children and adolescents with chronic gastroduodenal pathology after inpatient or outpatient treatment using enteral oxygen therapy is carried out. Studies will be conducted on the content in the peripheral blood in patients: hemoglobin (HGB, Hb, g/dL), erythrocytes (RBC, n x 1012/L), the content of hemoglobin in the erythrocyte (MCH, pg/cell), concentration in the erythrocyte of hemoglobin ( MCHC, g/dL). EFGDS is performed with an assessment of the endoscopic picture of the visible mucous membranes of the stomach and duodenum, according to the criteria of the generally accepted Sydney classification (1990, with a modification of 1996), with a description of the visible mucous organ: the presence of areas of hyperemia, ulcers, atrophy, hypertrophy, scarring.

  6 weeks

• Esofibrogastroduodenoscopy after rehabilitation.

  After rehabilitation measures using enteral oxygen therapy, repeated esofibrogastroduodenoscopy (EFGDS) will be performed. EFGDS is carried out with an assessment of the endoscopic picture of the visible mucous membranes of the stomach and duodenum according to the criteria of the generally accepted Sydney classification (1990, with a modification of 1996), with a description of the visible mucous organ: the presence of areas of hyperemia, ulcers, atrophy, hypertrophy, scarring (visual description).

  2 weeks

Secondary Outcomes (1)

• Statistical data processing.

  8 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Enteral oxygen therapy

Interventions

Enteral oxygen therapy DRUG

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

Also known as: Standard recreational activities for children after inpatient treatment.

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

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan: lead

Study Sites (1)

Tashkent Pediatric Medical Institute

Tashkent, 100140, Uzbekistan

Location

MeSH Terms

Conditions

Peptic Ulcer; Duodenal Ulcer; Gastritis

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastroenteritis

Study Officials

• Shokhida Turdieva, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: МD, associate professor of the Department "Outpatient care"

Model Details: Comparison of 2 mutually comparable patient groups.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 11, 2021
• Study Start: April 30, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)