Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
FEMALE
NCT07202481

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

Led by Federal University of Minas Gerais · Updated on 2026-03-24

25

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

Sponsors

F

Federal University of Minas Gerais

Lead Sponsor

M

Max Nutri

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 59Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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).

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Trial Site Locations

Total: 1 location

1

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil, 30130-100

Actively Recruiting

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Research Team

S

Simone de Vasconcelos Generoso, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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