The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
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: Probiotic, Prebiotic.
- Кому может быть актуально
- Состояния в реестре: Spinal Cord Injury. Базовые параметры: от 18 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
- Швейцария
- 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
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
Обзор
The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints. The main questions this trail aims to answer are: * what are the effects of the supplementation on gastrointestinal symptoms? * what are the effects of the supplementation on gut microbiome composition? * what are the effects of the supplementation on inflammatory serum markers? * what are the effects of the supplementation on gastrointestinal transit time? Participants will: * take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week "wash-out period" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement. * visit the study center for four appointments, during which various measurements will be performed.
Вмешательства
- Пищевая добавка Probiotic
Participants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet. - Пищевая добавка Prebiotic
Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
Первичные конечные точки
- Gastrointestinal symptoms [Срок оценки: Before and after eight weeks of intake of the dietary supplement.]
Вторичные конечные точки (3)
- Gut microbiome composition [Срок оценки: Before and after eight weeks of intake of the dietary supplement.]
- Inflammatory markers [Срок оценки: Before and after eight weeks of intake of the dietary supplement.]
- Gastrointestinal transit time [Срок оценки: Before and after eight weeks of intake of the dietary supplement.]
Критерии участия
Inclusion Criteria (at screening):
- Age: ≥ 18 years
- Sex: male and female.
- Chronic SCI (>1 year post-injury)
- Individuals with para- and tetraplegia (American Spinal Cord Injury (ASIA) Impairment Scale (AIS) score A-D)
- Having significant gastrointestinal complaints, indicated with "yes" at screening and by a GIQLI questionnaire score below 110 at baseline
- Signed written informed consent
Exclusion Criteria (at screening):
- Antibiotic use within the last four weeks before starting the study
- Major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet
- Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis
- Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis
- Concurrent participation in other clinical trials investigating or potentially affecting GI health
- Insufficient German language skills to follow the study procedures
- Pregnancy (anamnestic)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Swiss Paraplegic Research — Nottwil
Публикации
- Trunz J, Schmandt C, Hertig-Godeschalk A, Glisic M, Stoyanov J, Perret C. Probiotic and Prebiotic Supplementation for Gastrointestinal Discomfort in Chronic Spinal Cord Injury (PRO-GIDSCI): A Randomized Controlled Crossover Trial Protocol. Methods Protoc. 2026 Jan 17;9(1):14. doi: 10.3390/mps9010014. PMID 41562992
Идентификаторы
NCT: NCT06870331 · 2024-25