To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children. (NCT04702542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Uzbekistan320 participantsStarted 2022-04-30
Plain-language 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.
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initial clinical examination of children and adolescents at risk of CGDP.
Timeframe: 2 weeks
2
Identification of Helicobacter pylori infection.
Timeframe: 2 weeks
3
Esofibrogastroduodenoscopy at the start of the study
Timeframe: 2 weeks
4
Treatment of identified patients.
Timeframe: 6 weeks
5
Rehabilitation of patients using enteral oxygen therapy.
Timeframe: 6 weeks
6
Esofibrogastroduodenoscopy after rehabilitation.
Timeframe: 2 weeks
Trial details
NCT IDNCT04702542
SponsorTashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan