Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Spinal Cord Injuries, Gut Microbiome. Базовые параметры: 18 лет — 85 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
- США
- 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 Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \[within 6 weeks of injury\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.
Подробное описание
Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.
For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.
The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab
For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements \[CDEs\], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 \[PHQ9\] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
Первичные конечные точки
- Neurological impairment - Injury level by ISNCSCI [Срок оценки: Baseline]
- Neurological impairment - Injury level by AIS [Срок оценки: Baseline]
- Neurological impairment - completeness of injury by ISNCSCI [Срок оценки: Baseline]
- Neurological impairment - completeness of injury by AIS [Срок оценки: Baseline]
- Neurological impairment - Injury level by ISNCSCI [Срок оценки: Month 6]
- Neurological impairment - Injury level by AIS [Срок оценки: Month 6]
- Neurological impairment - completeness of injury by ISNCSCI [Срок оценки: Month 6]
- Neurological impairment - completeness of injury by AIS [Срок оценки: Month 6]
- Neurological impairment - Injury level by ISNCSCI [Срок оценки: Month 12]
- Neurological impairment - Injury level by AIS [Срок оценки: Month 12]
Вторичные конечные точки (12)
- Diet [Срок оценки: Baseline]
- Diet [Срок оценки: Month 1]
- Diet [Срок оценки: Month 6]
- Diet [Срок оценки: Month 12]
- Physical activity - PARA-SCI [Срок оценки: Baseline]
- Physical activity - CDEs [Срок оценки: Baseline]
- Physical activity - PARA-SCI [Срок оценки: Month 1]
- Physical activity - CDEs [Срок оценки: Month 1]
- Physical activity - PARA-SCI [Срок оценки: Month 6]
- Physical activity - CDEs [Срок оценки: Month 6]
- Physical activity - PARA-SCI [Срок оценки: Month 12]
- Physical activity - CDEs [Срок оценки: Month 12]
Критерии участия
Критерии включения
- 18-85 years of age
- diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
- classification of A, B, C (motor complete, incomplete).
Критерии исключения
- Women who are pregnant prior to consent
- neurological impairment other than SCI
- self-reported history of Crohn's disease or diverticulitis
- irritable bowel syndrome
- gastric blockage/obstruction or swallowing disorder
- prior GI surgery
- intrathecal pump
- concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).
- able to ambulate
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- The University of Alabama at Birmingahm — Birmingham
Идентификаторы
NCT: NCT05670288 · IRB-300010011 · 90SIMS0020