Actively Recruiting
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
Led by Federal University of Minas Gerais · Updated on 2026-03-24
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Federal University of Minas Gerais
Lead Sponsor
M
Max Nutri
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial focuses on women aged 18 to 59 with functional constipation who do not consume enough dietary fiber. The study aims to understand whether adding dietary fibers can improve bowel movements and to compare the effects of two types of fibers: fructooligosaccharide and psyllium. Researchers want to see if one fiber is more effective than the other while monitoring any side effects from fiber intake. Participants will consume 20 grams of fiber daily for six days, split into two doses of 10 grams each. The study uses a crossover design, where participants randomly start with either fiber A (psyllium) or fiber B (fructooligosaccharide) after an initial control period. Each fiber phase is followed by scintigraphic imaging to assess intestinal transit, with a seven-day washout period separating the two fiber treatments. During the trial, participants will keep daily records of their bowel habits and diet. Researchers will assess colonic transit time, gastric emptying, bowel function, quality of life, fecal microbiota, and short-chain fatty acids at various points. The study includes regular visits for imaging and data collection, with the entire process lasting several weeks. Safety and adherence will be closely monitored throughout the trial.
CONDITIONS
Brief Title
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 59 years
- Willingness to sign the Informed Consent Form
- No restrictions on 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 stop using laxatives at least 4 days before 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 will not qualify if you...
- Diagnosis of diabetes, severe hyperthyroidism, or hypothyroidism
- Use of opioid medications
- Delayed gastric emptying at 4 hours during the placebo period (excluded from final analysis)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo scintigraphic imaging and data collection to establish baseline measurements before starting fiber interventions.
1 visit (in-person)
Duration - 6 days
Participants consume one type of fiber supplement (Psyllium powder or Fructooligosaccharide) for 6 days while bowel function is monitored. At the end, scintigraphic imaging and data collection are repeated.
1 visit at the end of the treatment period (in-person)
Duration - 7 days
Participants undergo a 7-day washout period without fiber supplements to clear the previous intervention.
No visits during this period
Duration - 6 days
Participants consume the alternate fiber supplement for 6 days with ongoing bowel function assessment. Scintigraphic imaging and data collection occur again at the end.
1 visit at the end of the treatment period (in-person)
Trial Site Locations
Total: 1 location
1
School of Nursing, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
Research Team
S
Simone de Vasconcelos Generoso, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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