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

Primary Purpose

Gastritis Chronic, Gastroduodenitis, Peptic Ulcer

Status
Active
Phase
Not Applicable
Locations
Uzbekistan
Study Type
Interventional
Intervention
Enteral oxygen therapy
Sponsored by
Tashkent Pediatric Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastritis Chronic focused on measuring children, duodenal ulcer, gastritis, gastroduodenitis, Helicobacter pylori, oxygen therapy, rehabilitation, peptic ulcer, teenagers

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tashkent Pediatric Medical Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.
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).
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).
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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 3, 2021
Last Updated
October 21, 2022
Sponsor
Tashkent Pediatric Medical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04702542
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2020 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tashkent Pediatric Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis Chronic, Gastroduodenitis, Peptic Ulcer, Duodenal Ulcer
Keywords
children, duodenal ulcer, gastritis, gastroduodenitis, Helicobacter pylori, oxygen therapy, rehabilitation, peptic ulcer, teenagers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparison of 2 mutually comparable patient groups.
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enteral oxygen therapy for the improvement of children with chronic gastroduodenal pathology.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enteral oxygen therapy
Other Intervention Name(s)
Standard recreational activities for children after inpatient treatment.
Intervention Description
Enteral oxygen therapy during the rehabilitation period of patients with CGDP.
Primary Outcome Measure Information:
Title
Initial clinical examination of children and adolescents at risk of CGDP.
Description
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).
Time Frame
2 weeks
Title
Identification of Helicobacter pylori infection.
Description
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.
Time Frame
2 weeks
Title
Esofibrogastroduodenoscopy at the start of the study
Description
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).
Time Frame
2 weeks
Title
Treatment of identified patients.
Description
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).
Time Frame
6 weeks
Title
Rehabilitation of patients using enteral oxygen therapy.
Description
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.
Time Frame
6 weeks
Title
Esofibrogastroduodenoscopy after rehabilitation.
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Statistical data processing.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shokhida Turdieva, MD
Organizational Affiliation
Tashkent Pediatric Medical Institute
Official's Role
Study Director
Facility Information:
Facility Name
Tashkent Pediatric Medical Institute
City
Tashkent
ZIP/Postal Code
100140
Country
Uzbekistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Joint study of the regenerative properties of oxygen in chronic pathology of the gastrointestinal tract.

Learn more about this trial

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

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