Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Funct… (NCT07202481) | Clinical Trial Compass
RecruitingNot Applicable
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
Brazil25 participantsStarted 2026-03-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 59 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Colonic transit time
Timeframe: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.