Assessment of the Efficacy of E. Coli 5C in the Management of Post-Colonoscopy Symptoms
Assessment of the Efficacy of E. Coli 5C in the Management of Post-colonoscopy Symptoms: a Randomised, Double-blind, Placebo-controlled Trial.
This prospective, 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.
Обзор исследования
Статус
Вмешательство/лечение
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, 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, with patient global impression of change and clinically relevant improvement assessed only at Day 7 and Day 14. The primary efficacy endpoint is the between-group difference in change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to Day 14. Secondary assessments include numerical rating scale (NRS) symptom scores, stool consistency, bowel movement frequency, patient global impression of change, clinically relevant improvement in gastrointestinal symptoms, 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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Davide Sisti, PhD
- Номер телефона: +39 0722 303301
- Электронная почта: davide.sisti@uniurb.it
Места учебы
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Roma, Италия, 00191
- Clinica ARS Biomedica - Via Luigi Bodio 58
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Контакт:
- Dr. Fabrizio Ficuccilli's, MD
- Номер телефона: +39 06 3614941
- Электронная почта: info@arsbiomedica.it
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged between 18 and 80 years;
- Must have undergone a full colonoscopy on the date of enrolment.
Exclusion Criteria:
- Chronic Inflammatory Bowel Disease
- Complicated Diverticular Disease (DICA classification >3)
- Neoplastic disease of the colon
- Diagnosed microscopic colitis
- Therapeutic colonoscopy
- Immunocompromised patients (primary immunodeficiency, cancer undergoing active chemotherapy or immunotherapy, autoimmune disease undergoing immunosuppressive treatment)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Escherichia coli 5C (Colipral®)
Participants in this arm will receive Colipral® (dietary supplement containing Escherichia coli 5C), administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy. |
Dietary supplement containing Escherichia coli 5C (Colipral®) |
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Плацебо Компаратор: Placebo
Participants in this arm will receive placebo, identical in appearance but not containing the probiotic strain, administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy. |
Matching placebo |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14
Временное ограничение: Baseline to Day 14 after colonoscopy
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Between-group difference in change in gastrointestinal symptom severity from baseline to Day 14 after colonoscopy, assessed using the Gastrointestinal Symptom Rating Scale (GSRS). |
Baseline to Day 14 after colonoscopy
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in abdominal pain intensity score
Временное ограничение: 48 hours, Day 7, and Day 14 after colonoscopy
|
Between-group difference in abdominal pain intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy. |
48 hours, Day 7, and Day 14 after colonoscopy
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Change in abdominal bloating intensity score
Временное ограничение: 48 hours, Day 7, and Day 14 after colonoscopy
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Between-group difference in abdominal bloating intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy. |
48 hours, Day 7, and Day 14 after colonoscopy
|
|
Change in flatulence intensity score
Временное ограничение: 48 hours, Day 7, and Day 14 after colonoscopy
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Between-group difference in flatulence intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy. |
48 hours, Day 7, and Day 14 after colonoscopy
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Change in stool consistency assessed by Bristol Stool Form Scale
Временное ограничение: 48 hours, Day 7, and Day 14 after colonoscopy
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Between-group difference in stool consistency assessed using the Bristol Stool Form Scale at 48 hours, Day 7, and Day 14 after colonoscopy. |
48 hours, Day 7, and Day 14 after colonoscopy
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Change in frequency of bowel movements
Временное ограничение: 48 hours, Day 7, and Day 14 after colonoscopy
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Between-group difference in the mean number of daily bowel movements recorded at 48 hours, Day 7, and Day 14 after colonoscopy. |
48 hours, Day 7, and Day 14 after colonoscopy
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Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7 and Day 14
Временное ограничение: Day 7 and Day 14 after colonoscopy
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Between-group difference in the Global Assessment of Change of Gastrointestinal Symptoms at Day 7 and Day 14, measured using the Patient Global Impression of Change (PGIC), a 7-category ordinal scale ranging from "Very much worse" to "Very much improved". |
Day 7 and Day 14 after colonoscopy
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Proportion of participants with clinically relevant improvement in gastrointestinal symptoms
Временное ограничение: Day 7 and Day 14 after colonoscopy
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Proportion of participants with clinically relevant improvement in gastrointestinal symptoms, defined as a PGIC response of "Improved", assessed at Day 7 and Day 14 after colonoscopy. |
Day 7 and Day 14 after colonoscopy
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Use of rescue medication for gastrointestinal symptoms
Временное ограничение: Within 14 days after colonoscopy
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Proportion of participants who used concomitant or rescue medication for control of gastrointestinal symptoms within 14 days after colonoscopy. Type of drug, days of intake, and dose will also be recorded. |
Within 14 days after colonoscopy
|
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Frequency of adverse events
Временное ограничение: Within 14 days after colonoscopy
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Frequency and type of adverse events reported within 14 days after colonoscopy, including suspected allergic symptoms, nausea, vomiting, and other clinically relevant events. |
Within 14 days after colonoscopy
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Treatment tolerability score
Временное ограничение: Day 14 after colonoscopy
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Treatment tolerability assessed using a numerical score from 0 to 10 during the 14-day post-colonoscopy period. |
Day 14 after colonoscopy
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Adherence to treatment
Временное ограничение: Within 14 days after colonoscopy
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Adherence to study treatment, expressed as the percentage of doses taken compared with those expected during the 14-day observation period. |
Within 14 days after colonoscopy
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 139_16luglio2025_COLIPRAL_SIST
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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