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

N/ARecruitingNCT07202481

Federal University of Minas Gerais25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Constipation - Functional

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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 Exclusion Criteria * 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).

Outcomes

Primary Outcomes

Colonic transit time

Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal.

Time frame: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.

Secondary Outcomes

Gastric emptying

Gastric emptying will be evaluated using scintigraphy, with images obtained immediately after ingestion of the radiolabeled test meal and then hourly for 6 hours.

Time frame: This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest

Bowel function

Through questionnaires, the number of bowel movements and gastrointestinal symptoms experienced during the intervention period will be assessed

Time frame: The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.

Quality of life assessment

Using a validated questionnaire, the impact of constipation on the quality of life of women with constipation will be assessed.

Time frame: Assessed at baseline and following each treatment phase of the crossover trial

Fecal microbiota

Fecal samples will be collected before and after the intervention to assess the gut microbiota and short-chain fatty acids.

Time frame: Baseline and at the end of each 6-day intervention period

Fecal Short chain fatty acids

Fecal samples will be collected before and after the intervention to assess the short-chain fatty acids.