Набор скоро начнётся NCT06639516

Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial

Без фазы С лечением Acute Pancreatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Bifidobacterium longum, Placebo, Standard clinical treatment.
Кому может быть актуально: Состояния в реестре: Acute Pancreatitis. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this clinical trial is to investigate the impact of Bifidobacterium longum(BL) on the clinical prognosis of patients with acute pancreatitis(AP), to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL. Participants will be randomly assigned to two groups: the intervention group and the control group. They will receive: * Intervention group: Standard clinical treatment + BL capsules (10\^10 CFU), twice a day, for a total of 14 days; * Control group: Standard clinical treatment + placebo capsules, for a total of 14 days. A total of 60 patients will be included in this study.

Подробное описание

Rationale:The impairment of the intestinal mucosal barrier in patients with acute pancreatitis (AP) plays a crucial role in the progression to severe AP(SAP). Our previous research found that the early gut microbiota structure of AP patients is significantly different from that of healthy individuals, characterized by a marked increase in the relative abundance of conditional pathogens such as Escherichia coli and Shigella, while beneficial bacteria that produce short-chain fatty acids, such as Bifidobacterium, are significantly reduced, especially in patients with SAP. Bifidobacterium longum (BL), a well-known probiotic, has been used to treat a variety of diseases. In our previous animal experiments, we found that BL could alleviate pancreatic damage and inflammatory responses in AP mice and regulate the balance of the gut microbiota. Based on these findings, this study aims to assess the impact of BL on the clinical prognosis of AP patients through a randomized controlled trial, in order to provide a scientific basis for the application of BL in the treatment of AP and to further explore its potential clinical value.

Objective: The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP, to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.

Study design: Single-center, randomized, double-blind, placebo-controlled study.

Study population:60 adult patients with acute pancreatitis. Intervention: The intervention group receives standard clinical treatment plus BL capsules (10\^10 CFU), twice a day, for a total of 14 days; the control group receives standard clinical treatment plus placebo capsules, for a total of 14 days.

Main study parameters/endpoints: The primary endpoint is the number of days without SIRS within 14 days; the secondary endpoints include infectious complications (including fungal infections), parameters related to systemic inflammatory response, intestinal barrier function and gut microbiota composition, indicators related to recovery of intestinal function, antibiotic use, laboratory-related indicators, and clinical outcomes.

Safety: Throughout the study (or afterwards), treatment-emergent adverse events (TEAEs) were recorded, including gastrointestinal adverse reactions (abdominal pain, nausea, vomiting, bloating, or diarrhea) and allergic reactions, and adverse events that led to discontinuation of the study drug were documented.

Вмешательства

Пищевая добавка Bifidobacterium longum
Bifidobacterium longum
Пищевая добавка Placebo
Placebo
Комбинированный продукт Standard clinical treatment
Fasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs).

Первичные конечные точки

The number of days without SIRS within 14 days [Срок оценки: From randomization to 14 days after treatment]

Вторичные конечные точки (12)

Infectious complications [Срок оценки: During the whole study period including follow-up of 90 days]
Intestinal barrier function [Срок оценки: Through study completion, an average of 1 year]
Intestinal barrier function [Срок оценки: Through study completion, an average of 1 year]
Intestinal barrier function [Срок оценки: Through study completion, an average of 1 year]
Gut microbiota composition [Срок оценки: Baseline , 3 days，7 days and 14 days of treatment]
Systemic inflammatory response parameters (SIRS) [Срок оценки: Through study completion, an average of 1 year]
Systemic inflammatory response parameters (SIRS) [Срок оценки: Through study completion, an average of 1 year]
Systemic inflammatory response parameters (SIRS) [Срок оценки: Through study completion, an average of 1 year]
Gut function recovery-related indicators [Срок оценки: Through study completion, an average of 1 year]
Antibiotic usage [Срок оценки: Through study completion, an average of 1 year]
Mortality [Срок оценки: During the whole study period including follow-up of 90 days]
(New onset) transient/persistant (multiple) organ failure [Срок оценки: During the whole study period including follow-up of 90 days]

Критерии участия

Критерии включения

Age 18-75 year;
The diagnosis of acute pancreatitis according to the revised Atlanta classification;
The onset time of acute pancreatitis is within 48 hours;
APACHE II score of ≥8, or C-reactive protein \&amp;gt; 150 mg/L, or SIRS score of ≥3;
Signed the informed consent.