Systemic Sclerosis DIet for GastrointESTinal Symptoms

Официальное название

SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis

Обзор

This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.

Подробное описание

The rationale for keeping the diets (arms/interventions names) vague is it prevents other researchers from using these diets in their studies, minimizes expectation bias of patients (who can have preference for one diet over other) and prevents participants from trying other diets before end of study period in case they don't respond.

Вмешательства

• Поведенческое Diet 1: Restriction of fermentable carbohydrates
  6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms.
• Поведенческое Diet 2: Elimination of foods harmful to gut barrier and microbiome
  6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome
• Поведенческое Diet 3: Regular meal patterns, soluble fiber, and portion control
  6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.

Первичные конечные точки

• Change in Bloating severity [Срок оценки: Baseline to week 6]

Вторичные конечные точки (3)

• Change in Bloating severity [Срок оценки: Baseline to week 6]
• Change in Abdominal pain severity [Срок оценки: Baseline to week 6]
• Change in Overall GI symptom [Срок оценки: Baseline to week 6]

Критерии участия

Критерии включения

• Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria

.• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.

• Willingness and ability to comply with dietary intervention and study procedures.
• Ability to provide informed consent.

Критерии исключения

• Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.
• Use of systemic antibiotics within 4 weeks prior to baseline.
• History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).
• Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.
• Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.
• Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).
• Clinically significant self-reported (≥10 percent weight loss) in the last 3 months
• BMI less than 20
• Ongoing tube feeds or TPN
• Participating in another interventional trial
• Pregnancy or lactation, or planning pregnancy in the next 6 months

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

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07402226 · HUM00285136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗