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

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

This will test whether taking 20 g daily of psyllium or fructooligosaccharide for six days helps improve bowel movements and intestinal transit in adult women with functional constipation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 59 Years
• Sex: Female
• Sponsor: Federal University of Minas Gerais (Academic / other)
• Locations: 1 site (Belo Horizonte, Minas Gerais)
• Trial ID: NCT07202481 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adult women aged 18–59 with functional constipation who currently consume less than about 25–30 g of fiber per day, are non-smokers, and have no other gastrointestinal disease are ideal candidates.

Not a fit: Patients with diabetes, significant thyroid disease, opioid use, prior surgery affecting gastrointestinal transit, delayed gastric emptying at baseline, or those already meeting adequate fiber intake may not receive benefit from these interventions.

Why it matters

Potential benefit: If successful, the trial could identify which common fiber supplement more quickly improves bowel regularity and intestinal transit for women with functional constipation.

How similar studies have performed: Psyllium is well-supported by prior studies for relieving constipation and fructooligosaccharide has mixed evidence, so elements of this approach are established though direct short-term crossover comparisons with scintigraphy are less common.

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).

Where this trial is running

Belo Horizonte, Minas Gerais

• 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

Conditions Constipation - Functional