Gastritis ChronicNCT04702542
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
A study testing Enteral oxygen therapy in people with Gastritis Chronic and Gastroduodenitis, run by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan at 1 site in Uzbekistan.
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). Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastritis Chronic, Gastroduodenitis, Peptic Ulcer
- What is being tested?
- Enteral oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUzbekistan
- Study dates
- 30 Apr 2022to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology (CGDP) in Schoolchildren in the Primary Health Care System.
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.
Read the 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
- Being tested
- Enteral oxygen therapy
- Keywords
- children, duodenal ulcer, gastritis, gastroduodenitis, Helicobacter pylori, oxygen therapy, rehabilitation, peptic ulcer, teenagers
- Medical subject headings
- Peptic Ulcer, Duodenal Ulcer, Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral oxygen therapyDrug
Also called Standard recreational activities for children after inpatient treatment.
Enteral oxygen therapy during the rehabilitation period of patients with CGDP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Enteral oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start30 Apr 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of 2 mutually comparable patient groups.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turdieva Shokhida Tolkunovna, MD, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Investigators
- Shokhida Turdieva, MD, Study director, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702542
- Sponsor's protocol ID
- TashkentPediatricMI-2
- Status last verified
- Nov 2026
- First submitted
- 3 Jan 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Joint study of the regenerative properties of oxygen in chronic pathology of the gastrointestinal tract.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology (CGDP) in Schoolchildren in the Primary Health Care System.
- ClinicalTrials.gov ID
- NCT04702542
- Acronym / sponsor ID
- TashkentPediatricMI-2
- Conditions
- Gastritis Chronic, Gastroduodenitis, Peptic Ulcer, Duodenal Ulcer
- Keywords
- children, duodenal ulcer, gastritis, gastroduodenitis, Helicobacter pylori, oxygen therapy, rehabilitation, peptic ulcer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Tashkent State Medical University (Tashkent Pediatric Medical Institute), UzbekistanUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of 2 mutually comparable patient groups.
| Arm | Type | Receives |
|---|---|---|
| Enteral oxygen therapy for the improvement of children with chronic gastroduodenal pathology. | Experimental | Drug: Enteral oxygen therapyEnteral 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral oxygen therapyAlso: Standard recreational activities for children after inpatient treatment.Enteral oxygen therapy during the rehabilitation period of patients with CGDP. | Drug | Enteral oxygen therapy for the improvement of children with chronic gastroduodenal pathology. |
Primary outcome
Initial clinical examination of children and adolescents at risk of CGDP.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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
Time frame: 2 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 2 weeks
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).
1 secondary outcome
Statistical data processing.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Joint study of the regenerative properties of oxygen in chronic pathology of the gastrointestinal tract.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shokhida Turdieva, MD study director
Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral oxygen therapy in people with Gastritis Chronic and Gastroduodenitis, run by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial clinical examination of children and adolescents at risk of CGDP. (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.