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Идёт набор NCT07494968

Defining Objective Markers of Compliance for Dietary Therapies in IBS

Без фазы С лечением Irritable Bowel Syndrome

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: Diet A - elimination diet, Diet B - healthy eating diet.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome. Базовые параметры: 18 лет — 65 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
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Официальное название

Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial

Обзор

This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake

Подробное описание

The primary purpose of this study is to evaluate if an objective biomarker can be used to evaluate the amount of specific carbohydrate intake. It is to measure the coloration between Gluten immunogenic Peptides (GIP) and fructo-oligosaccharide intake(on 24-hour diet recall) at Week 4 to identify an objective biomarker for dietary content evaluation which is critical for dietary treatment.

The researchers hope GIP can be used to evaluate the amount of carbohydrate intake in clinical practice.)

Вмешательства

  • Поведенческое Diet A - elimination diet
    Combined oligosaccharide intake (fructans plus galacto-oligosaccharides) will be limited to \<0.50 grams per serving (same as above), while polyols, lactose, and fructose will not be limited.
  • Поведенческое Diet B - healthy eating diet
    The subjects will be instructed to regularly eat 3 meals and 3 snacks a day, never too much or too little each time, never to be hungry or too full; to eat in peace and quiet and to chew thoroughly; drinks at least 8 cups of fluids a day, reduce intake of fatty or spicy foods, coffee, alcohol; avoid soft drinks and carbonated beverages, chewing gums, and sweeteners that ends with -ol, and to eat fibers with focus on soluble fibers such as oats but distribute the intake evenly during the day

Первичные конечные точки

  • Correlation between fecal GIP excretion and fructo-oligosaccharide intake [Срок оценки: Week 4]
Вторичные конечные точки (3)
  • The Irritable Bowel Severity Scoring System (IBS-SSS) score [Срок оценки: Week 4]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) abdominal pain score [Срок оценки: Week 4]
  • PROMIS bloating score [Срок оценки: Week 4]

Критерии участия

Критерии включения

  • Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.
  • Aged 18-65 years at the time of screening
  • IBS-SSS of at least 175 at baseline

Критерии исключения

  • Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.
  • Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate/make changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.
  • Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
  • Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
  • BMI < 18.5
  • Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
  • History of appendectomy or cholecystectomy in the last 6 months.
  • Oral antibiotic use in the past 3 months
  • Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
  • Currently pregnant or breastfeeding.

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
Другое

Центры проведения

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07494968 · HUM00285706

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗