Constipation - FunctionalNCT07202481
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
A study testing Psyllium powder and Fructooligosaccharide in people with Constipation - Functional, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Psyllium powder and Fructooligosaccharide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Simone de Vasconcelos Generoso, PhD, 55(31) 98812-8650, simonenutufmg@gmail.com
About this study
Official title: 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
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)?
Read more
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
- Being tested
- Psyllium powder, Fructooligosaccharide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium powderDietary supplement
Psyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each)
FructooligosaccharideDietary supplement
Fructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Fructooligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic transit time
Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal.
Measured: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.
Secondary outcomes (5)
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.
Measured: This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest
Bowel function
Through questionnaires, the number of bowel movements and gastrointestinal symptoms experienced during the intervention period will be assessed
Measured: The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.
Quality of life assessment
Using a validated questionnaire, the impact of constipation on the quality of life of women with constipation will be assessed.
Measured: Assessed at baseline and following each treatment phase of the crossover trial
Fecal microbiota
Fecal samples will be collected before and after the intervention to assess the gut microbiota and short-chain fatty acids.
Measured: Baseline and at the end of each 6-day intervention period
Fecal Short chain fatty acids
Fecal samples will be collected before and after the intervention to assess the short-chain fatty acids.
Measured: Baseline and at the end of each 6-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start14 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Max Nutri
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Simone de Vasconcelos Generoso, PhD, Principal investigator, Department of Nutrition, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202481
- Sponsor's protocol ID
- 85835125.9.0000.5149
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07202481
- Acronym / sponsor ID
- 85835125.9.0000.5149
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Max Nutri
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber A | Experimental | Dietary Supplement: Psyllium powderIn 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. |
| Fiber B | Experimental | Dietary Supplement: FructooligosaccharideIn 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psyllium powderPsyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each) | Dietary supplement | Fiber A |
| FructooligosaccharideFructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each) | Dietary supplement | Fiber B |
Primary outcome
Colonic transit time
Time frame: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.
Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal.
5 secondary outcomes
Gastric emptying
Time frame: This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest
Bowel function
Time frame: The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.
Quality of life assessment
Time frame: Assessed at baseline and following each treatment phase of the crossover trial
Fecal microbiota
Time frame: Baseline and at the end of each 6-day intervention period
Fecal Short chain fatty acids
Time frame: Baseline and at the end of each 6-day intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone de Vasconcelos Generoso, PhD principal investigator
Department of Nutrition, Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium powder and Fructooligosaccharide in people with Constipation - Functional, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone de Vasconcelos Generoso, PhD (55(031) 988128650, simonenutufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic transit time (time frame: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.