NCT07202481 Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
| NCT ID | NCT07202481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Constipation - Functional |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-03-14 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-03-14 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Simone de Vasconcelos Generoso, PhD
PRINCIPAL INVESTIGATOR
Department of Nutrition, Federal University of Minas Gerais
Frequently Asked Questions
Who can join the NCT07202481 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 59 Years, studying Constipation - Functional. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202481 currently recruiting?
Yes, NCT07202481 is actively recruiting participants. Contact the research team at simonenutufmg@gmail.com for enrollment information.
Where is the NCT07202481 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT07202481 clinical trial?
NCT07202481 is sponsored by Federal University of Minas Gerais. The principal investigator is Simone de Vasconcelos Generoso, PhD at Department of Nutrition, Federal University of Minas Gerais. The trial plans to enroll 25 participants.