Effect of Escherichia Coli 5C (Colipral®) on Post-Colonoscopy Gastrointestinal Symptoms
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: Colipral®, Placebo.
- Кому может быть актуально
- Состояния в реестре: Post-Colonoscopy Gastrointestinal Symptoms. Базовые параметры: 18 лет — 80 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Effectiveness of Escherichia Coli 5C in the Management of Post-Colonoscopy Symptoms: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Обзор
This prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Escherichia coli 5C (Colipral®) in adult patients undergoing diagnostic colonoscopy. Participants will be randomized in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately after colonoscopy. The study aims to determine whether Colipral® reduces post-colonoscopy gastrointestinal symptoms compared with placebo, using validated symptom and stool assessment tools, patient-reported global improvement, and safety monitoring.
Подробное описание
Patients undergoing diagnostic colonoscopy may experience gastrointestinal discomfort in the days following the procedure, which may be related to alterations in the intestinal microbiota induced by bowel preparation. This study is designed to evaluate whether supplementation with Escherichia coli 5C (Colipral®) can reduce post-colonoscopy gastrointestinal symptoms compared with placebo.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. Adult patients undergoing complete diagnostic colonoscopy will be screened according to predefined inclusion and exclusion criteria and enrolled after written informed consent. Participants will be randomly assigned in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately following colonoscopy. The study treatment will be administered as 2 capsules per day, with 1 capsule in the morning and 1 capsule in the evening after dinner.
Clinical assessments will be performed at baseline and at 48 hours, 7 days, and 14 days after colonoscopy. The primary efficacy endpoint is the between-group difference in change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to Day 7. Secondary efficacy assessments include GSRS score changes at additional time points, numerical rating scale (NRS) symptom scores, stool consistency, bowel movement frequency, patient global impression of change, use of rescue medication, treatment adherence, tolerability, and adverse events.
The study is designed to assess both the clinical efficacy and safety of Colipral® in the management of post-colonoscopy symptoms in adult patients.
Вмешательства
- Пищевая добавка Colipral®
Dietary supplement containing Escherichia coli 5C (Colipral®) - Другое Placebo
Matching placebo
Первичные конечные точки
- Change in Gastrointestinal Symptom Rating Scale (GSRS) score [Срок оценки: Baseline to Day 7 after colonoscopy]
Вторичные конечные точки (12)
- Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14 [Срок оценки: Baseline to Day 14 after colonoscopy]
- Change in abdominal pain intensity score [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Change in abdominal bloating intensity score [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Change in flatulence intensity score [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Change in stool consistency assessed by Bristol Stool Form Scale [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Change in frequency of bowel movements [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7 [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Proportion of participants with clinically relevant improvement in gastrointestinal symptoms [Срок оценки: 48 hours, Day 7, and Day 14 after colonoscopy]
- Use of rescue medication for gastrointestinal symptoms [Срок оценки: Within 14 days after colonoscopy]
- Frequency of adverse events [Срок оценки: Within 14 days after colonoscopy]
- Treatment tolerability score [Срок оценки: Day 14 after colonoscopy]
- Adherence to treatment [Срок оценки: Within 14 days after colonoscopy]
Критерии участия
Критерии включения
- Age between 18 and 80 years
- Complete diagnostic colonoscopy with achievement of the cecal fundus
- Accepted written informed consent for study participation obtained prior to the start of the study
Критерии исключения
- Chronic inflammatory bowel disease
- Complicated Diverticular Disease (DICA >3)
- Suspected or known colorectal malignancy on index colonoscopy
- Diagnosed microscopic colitis
- Operative colonoscopy
- Severe chronic gastrointestinal symptoms judged by the investigator to interfere with the evaluation of study endpoints
- Subjects who are immunosuppressed or on systemic immunosuppressive treatment, including patients with primary or acquired immunodeficiency, oncological disease on active treatment with chemotherapy/immunotherapy, or autoimmune diseases on immunosuppressive treatment
- Taking probiotics, prebiotics, or synbiotics within 2-4 weeks prior to enrollment
- Antibiotic therapy within 4 weeks prior to enrollment
- Lack of acceptance of written informed consent
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
Италия · 1 центр
- University of Urbino Carlo Bo, Urbino, Italy — Urbino
Идентификаторы
NCT: NCT07519616 · 139_16luglio2025_COLIPRAL