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

ConditionConstipation - Functional
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-59
SponsorFederal University of Minas Gerais

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Fiber AExperimental treatment 1 intervention
Group B: Fiber BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Colonic transit time

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

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

Secondary outcomes

1

Gastric emptying

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

Time frame
This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest
2

Bowel function

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

Time frame
The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.
3

Quality of life assessment

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

Time frame
Assessed at baseline and following each treatment phase of the crossover trial
4

Fecal microbiota

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal University of Minas Gerais

Lead sponsor

Max Nutri

Collaborator

Source ClinicalTrials.gov
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