Fermented Foods and Bowel Health in SCI

Официальное название

High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI

Обзор

The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are: 1. Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI? 2. Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation? Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes. Participants will: * Consume study foods daily for 10 weeks * Attend 2 in-person study visits * Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials * Complete bowel health questionnaires and dietary recalls * Undergo Sitz marker testing with abdominal X-rays to assess colonic transit * Participate in biweekly monitoring contacts throughout the study period

Вмешательства

• Другое fermented foods
  Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
• Другое Control diet
  Participants randomized to the control arm will receive non-fermented versions of the base foods consumed by the fermented food arm and will be instructed to avoid fermented foods during the trial.
• Устройство Sitz Marker Test
  Colonic transit time will be assessed using the Sitz marker test, a standardized radiopaque marker method for evaluating bowel motility. Participants will swallow a capsule containing radiopaque markers, and abdominal X-rays will be obtained on day 5 to determine the number and distribution of retained markers throughout the colon. Greater marker retention indicates slower colonic transit, whereas fewer retained markers indicate faster transit and improved bowel motility.

Первичные конечные точки

• Fecal microbiome composition assessed by shotgun metagenomic sequencing [Срок оценки: Baseline, weeks 5 and 10]
• Gut microbiome functional potential measured by shotgun metagenomic sequencing [Срок оценки: Baseline, week 5, and week 10]
• Fecal calprotectin measured by ELISA [Срок оценки: Baseline, weeks 5 and 10]
• Fecal Short Chain Fatty Acid measured by LC-MS/MS [Срок оценки: Baseline, weeks 5 and 10]

Вторичные конечные точки (4)

• Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score [Срок оценки: Baseline, weeks 5 and 10]
• Colonic transit measured by the Sitz marker test [Срок оценки: Baseline, week 10]
• Constipation severity measured by the Constipation Severity Instrument [Срок оценки: Baseline, weeks 5 and 10]
• Stool consistency measured by the Bristol Stool Form Scale [Срок оценки: Baseline, weeks 5 and 10]

Критерии участия

Критерии включения

• Adults aged 18-70 years
• At least 1 year post-onset of spinal cord injury, consistent with chronic spinal cord injury
• Traumatic spinal cord injury involving cervical or thoracic levels
• American Spinal Injury Association Impairment Scale classification A-D
• Medically stable, with no recent hospitalizations or acute illnesses
• Able to safely consume study foods, including fermented and control food products
• Experiencing neurogenic bowel dysfunction, defined by at least one of the following:

• Three or fewer bowel movements per week
• More than 60 minutes required per bowel care routine
• Symptoms of incomplete evacuation
• Abdominal distension
• Fecal incontinence
• Established and stable bowel program, defined as a consistent individualized routine of timing, frequency, and evacuation methods that has remained unchanged for at least 4 weeks before enrollment

Критерии исключения

• Antibiotic use within the past 4 weeks
• Active gastrointestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal obstruction
• Current intake of probiotics or fermented foods exceeding 3 servings per day
• Pregnancy or breastfeeding
• Recent major bowel surgery within the past 12 weeks
• Unresolved fecal impaction
• Unstable bowel regimen that could interfere with accurate motility assessment
• Inability to safely undergo Sitz marker testing, including any of the following:

• Inability to swallow the capsule
• Pregnancy, due to radiation exposure
• Contraindication to abdominal X-ray procedures

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ohio State University — Columbus

Идентификаторы

NCT: NCT07640152 · 1519842

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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