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

NCT07202481 | Recruiting DMC

• 1 other identifier: 85835125.9.0000.5149
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Colonic transit time

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

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

Secondary Outcomes (5)

• Gastric emptying

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

• Bowel function

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

• Quality of life assessment

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

• Fecal microbiota

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

• Fecal Short chain fatty acids

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

Study Arms (2)

Fiber A

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.

Dietary Supplement: Psyllium powder

Fiber B

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.

Dietary Supplement: Fructooligosaccharide

Interventions

Psyllium powder DIETARY_SUPPLEMENT

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

Fiber A

Fructooligosaccharide DIETARY_SUPPLEMENT

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

Fiber B

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Max Nutri: collaborator

Study Sites (1)

School of Nursing, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Interventions

fructooligosaccharide

Study Officials

• Simone de Vasconcelos Generoso, PhD

  Department of Nutrition, Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone de Vasconcelos Generoso, PhD

CONTACT

55(031) 988128650; simonenutufmg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 1, 2025
• Study Start: March 14, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)