Psyllium versus fructooligosaccharide for improving bowel transit in women with functional constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized crossover trial enrolls women aged 18–59 with functional constipation who consume less than recommended dietary fiber. Each participant will undergo 6-day periods of 20 g/day fiber (divided into two 10 g doses) with psyllium, fructooligosaccharide, and a control in random order, and will keep daily bowel and diet records. At the end of each period participants will have scintigraphic nuclear medicine imaging to measure intestinal transit, and laxatives are stopped before imaging. The crossover design allows within-person comparisons of effectiveness and side effects between the two fibers and control.

Why it matters

Who can join: the full rules

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).

Where it's running

• School of Nursing, Federal University of Minas Gerais
  Belo Horizonte, Minas Gerais, Brazil Recruiting

Study contacts

• Principal investigator: Simone de Vasconcelos Generoso, PhD — Department of Nutrition, Federal University of Minas Gerais
• Study coordinator: Simone de Vasconcelos Generoso, PhD
• Email: simonenutufmg@gmail.com
• Phone: 55(031) 988128650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.