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NCT Number: NCT07202481

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

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.

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Key information

Conditions

Constipation - Functional

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location status: Recruiting

Location contact

Simone de Vasconcelos Generoso, PhD

CONTACT

[email protected]

55(31) 98812-8650

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psyllium powder

Dietary Supplement

Psyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each)

Fructooligosaccharide

Dietary Supplement

Fructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each)

Primary outcomes

  1. Colonic transit time

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

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

Secondary outcomes

  1. Gastric emptying

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

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

  2. Bowel function

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

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

  3. Quality of life assessment

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

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

  4. Fecal microbiota

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

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

  5. Fecal Short chain fatty acids

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Simone de Vasconcelos Generoso, PhD

CONTACT

[email protected]

55(031) 988128650

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Max Nutri

Registry information

Official study title

Effects of Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit Time in Women Diagnosed With Functional Constipation: A Randomized, Crossover, Double-Blind Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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