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

Peptic Ulcer Clinical Trial

Official title:

To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology (CGDP) in Schoolchildren in the Primary Health Care System.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04702542
• Other study ID #: TashkentPediatricMI-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2020
• Est. completion date: December 30, 2028

Study information

• Verified date: December 2023
• Source: Tashkent Pediatric Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastritis
• Gastritis Chronic
• Gastroduodenitis
• Peptic Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Uzbekistan	Tashkent Pediatric Medical Institute	Tashkent

Sponsors (1)

Lead Sponsor	Collaborator
Tashkent Pediatric Medical Institute

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Statistical data processing.	Statistical data processing will be carried out using Microsoft Excel 7.0 for Windows-XP, with the definition of the arithmetic mean (M) and standard deviation (s). When characterizing the statistical significance of the differences, the Student's t-test was used, with the determination of the limit of the confidence interval based on the Student's distribution table. The results will be assessed as statistically significant at a probability level of P <0.05. Comparison is made between groups of patients receiving enteral oxygen therapy and those not receiving.	8 weeks