The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

Обзор

Helicobacter pylori (H. pylori) is one of the most common chronic infections worldwide. The mode of transmission of H. pylori is through the fecal-oral or oral-oral routes. Chronic gastritis has been linked to helicobacter pylori (H. pylori) infection. Peptic ulcer disease, gastric adenocarcinoma, and gastric lymphoma are all linked to this condition . In Egypt, a high prevalence of H. pylori infections has been reported, ranging from 70% in the general population , 73% among school children , up to 88% in patients with chronic active HCV . In 2007, the American College of Gastroenterology estimated that the cure rate for H. pylori infections was 70-85 percent with the use of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole . children with H. pylori infection do not have severe digestive symptoms. pylori infection represents a key factor in the pathogenesis of duodenal ulcer and chronic gastritis in children. In addition, H. pylori infection has also been reported to have extra-digestive consequences . A recent comprehensive evaluation found that sequential and conventional triple treatment had a cure rate of 84% . The infected macrophage is unable to create enough 1,25-(OH)2D to control the synthesis of AMP cathelicidin when it is vitamin D deficient . vitamin D has a powerful systemic antibacterial impact by enhancing the activity of monocytes and macrophages. Most illnesses seem to benefit from a vitamin D-rich condition . Vitamin D-deficient subjects might be more prone to developing H. pylori infection .

Подробное описание

To assess the efficacy of adding vitamin D supplement as adjuvant therapy in eliminating helicobacter pylori infection.

Вмешательства

• Препарат Lansoprazole
  oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day
• Препарат amoxicillin
  amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day
• Препарат clarithromycin
  oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day
• Препарат vitamin D
  vitamin D therapy of 4000-5000 units daily in patients over 12 months old.

Первичные конечные точки

• cure rate after treatment [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients aged between 1 to 16 years old who present with helicobacter pylori infection diagnosed by positive stool antigen test for helicobacter pylori infection presented with weight loss, abdominal pain, or failure to surive symptoms for at least 1 month.

Критерии исключения

\- 1. Known hypersensitivity to PPIS or antibiotics. 2. Patients who have previously received helicobacter pylori eradication treatment, corticosteroids/immunosuppressive treatment and acid suppressive treatment in the prior 2 months.

3\. History of systemic inflammatory or autoimmune disorders, gastric surgery, renal failure, liver cirrhosis and malignancies 4. Abnormal birth history such as premature birth and asphyxia or with severe disease history, such as genetic metabolic disease, congenital dysplasia, feeding difficulties, severe malnutrition, repeated respiratory diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06964334 · vit D supplement h.pylori

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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