Recruiting

Fructooligosaccharide and Psyllium for Functional Constipation in Women

What is being tested

Psyllium powder

+ Fructooligosaccharide

Dietary Supplement

Who is being recruted

From 18 to 59 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorFederal University of Minas Gerais

Study ContactSimone de Vasconcelos Generoso, PhD

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding whether certain dietary fibers can help women who experience functional constipation, a condition where bowel movements are infrequent or difficult. The trial examines two specific fibers, fructooligosaccharide and psyllium, to see if they can improve bowel function in women who typically do not consume enough dietary fiber. The research aims to determine if these fibers can make a difference, and if one works better than the other in easing constipation symptoms. This is important for finding effective, non-pharmaceutical ways to manage constipation, which can significantly impact daily life. In the study, participants will take 20 grams of fiber daily, split into two doses of 10 grams each, over a period of 6 days. To measure the effects of the fiber, participants will undergo a special imaging test called scintigraphy, which helps track how quickly food moves through the intestines. Participants will also keep a daily log of their bowel movements and what they eat. By comparing the effects of the fibers with a control, the study seeks to uncover any benefits in relieving constipation and note any side effects, contributing valuable information to dietary management strategies for this condition.

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

NCT07202481

Principal SponsorFederal University of Minas Gerais

Study ContactSimone de Vasconcelos Generoso, PhD

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

11 inclusion criteria required to participate

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

Show More Criteria

3 exclusion criteria prevent from participating

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

In this arm, participants start by undergoing scintigraphic imaging and data collection for the control period. Then, in a randomized order, they receive Fiber A for 6 days, at a dose of 20 g per day divided into two 10 g doses, after which scintigraphic imaging and data collection are repeated. Following a 7-day washout period, participants begin Fiber B consumption, also at 20 g per day divided into two 10 g doses, and return for new scintigraphic imaging and data collection.

Group II

Experimental

In this arm, participants start by undergoing scintigraphic imaging and data collection for the control period. Then, in a randomized order, they receive Fiber B for 6 days, at a dose of 20 g per day divided into two 10 g doses, after which scintigraphic imaging and data collection are repeated. Following a 7-day washout period, participants begin Fiber A consumption, also at 20 g per day divided into two 10 g doses, and return for new scintigraphic imaging and data collection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, BrazilOpen School of Nursing, Federal University of Minas Gerais in Google Maps

Recruiting

One Study Center