Status:
RECRUITING
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
Lead Sponsor:
Federal University of Minas Gerais
Collaborating Sponsors:
Max Nutri
Conditions:
Constipation - Functional
Eligibility:
FEMALE
18-59 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07202481
Start Date
October 1 2025
End Date
December 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100