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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
School of Nursing, Federal University of Minas Gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Simone de Vasconcelos Generoso, PhD
simonenutufmg@gmail.com
55(031) 988128650
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 25
Treatments
Experimental: Fiber A
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.
Experimental: Fiber B
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.
Related Therapeutic Areas
Sponsors
Leads: Federal University of Minas Gerais
Collaborators: Max Nutri

This content was sourced from clinicaltrials.gov