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.
Verified date | December 2023 |
Source | Tashkent Pediatric Medical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Uzbekistan | Tashkent Pediatric Medical Institute | Tashkent |
Lead Sponsor | Collaborator |
---|---|
Tashkent Pediatric Medical Institute |
Uzbekistan,
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 (HELIKĀ® 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 |
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