Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial

Официальное название

Effects of Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit Time in Women Diagnosed With Functional Constipation: A Randomized, Crossover, Double-Blind Clinical Trial

Обзор

The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are: * In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function? * Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)? The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact. Participants will: * Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each. * Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy. * Keep a daily record of bowel habits and dietary intake.

Вмешательства

• Пищевая добавка Psyllium powder
  Psyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each)
• Пищевая добавка Fructooligosaccharide
  Fructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each)

Первичные конечные точки

• Colonic transit time [Срок оценки: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.]

Вторичные конечные точки (5)

• Gastric emptying [Срок оценки: This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest]
• Bowel function [Срок оценки: The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.]
• Quality of life assessment [Срок оценки: Assessed at baseline and following each treatment phase of the crossover trial]
• Fecal microbiota [Срок оценки: Baseline and at the end of each 6-day intervention period]
• Fecal Short chain fatty acids [Срок оценки: Baseline and at the end of each 6-day intervention period]

Критерии участия

Критерии включения

• Female participants aged 18-59 years.
• Willingness to sign the Informed Consent Form .
• No restrictions on the consumption of egg or gluten.
• No history or diagnosis of gastrointestinal diseases other than functional constipation.
• Non-smokers.
• No use of prebiotics, probiotics, synbiotics, or antibiotics at least 10 days prior to the study.
• No previous surgery affecting gastrointestinal transit.
• Willingness to discontinue the use of laxatives at least 4 days prior to scintigraphic imaging.
• Participants who do not consume adequate dietary fiber (25-30 g/day) as assessed by dietary recall.
• No confirmed or suspected pregnancy during the study.
• No self-reported menopause

Критерии исключения

• Diagnosis of diabetes, severe hyperthyroidism, or hypothyroidism.
• Use of opioid medications.
• Delayed gastric emptying at 4 hours during the placebo period (participants meeting this criterion will be excluded from final analysis).

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• School of Nursing, Federal University of Minas Gerais — Belo Horizonte

Идентификаторы

NCT: NCT07202481 · 85835125.9.0000.5149

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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