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

Federal University of Minas Gerais

Status: Enrolling

Conditions: Constipation - Functional

Treatments: Dietary Supplement: Fructooligosaccharide; Dietary Supplement: Psyllium powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07202481

85835125.9.0000.5149

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Fiber A

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Psyllium powder

Fiber B

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fructooligosaccharide