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

NCT07202481 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-24

No results posted yet for this study

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 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

  • Constipation - Functional

Interventions

DIETARY_SUPPLEMENT

Psyllium powder

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

DIETARY_SUPPLEMENT

Fructooligosaccharide

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

Sponsors & Collaborators

  • Max Nutri

    collaborator UNKNOWN

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Simone de Vasconcelos Generoso, PhD · Department of Nutrition, Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-14
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202481 on ClinicalTrials.gov