Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
NCT ID: NCT02140749
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-04-30
2014-12-31
Brief Summary
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Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.
Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4 weeks.
Study population: Human subjects with functional constipation according to ROMEIII criteria (total n=120; male and female; 18-75 yr).
Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral chews.
Main study parameters: The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. Secondary outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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sc-FOS 2g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks)
sc-FOS 2g/day
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
Placebo
Chewing tablets without short-chain Fructooligosaccharides
sc-FOS 4g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks)
sc-FOS 4g/day
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
Placebo
Chewing tablets without short-chain Fructooligosaccharides
sc-FOS 8g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks)
sc-FOS 8g/day
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
Placebo
Chewing tablets without short-chain Fructooligosaccharides
Interventions
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sc-FOS 2g/day
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
sc-FOS 4g/day
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
sc-FOS 8g/day
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
Placebo
Chewing tablets without short-chain Fructooligosaccharides
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agree to study design (signed informed consent)
* At least two of the following symptoms ≥25% of the time with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to inclusion (ROME III criteria for functional constipation):
* straining, lumpy or hard stool
* sensation of incomplete evacuation
* sensation of anorectal obstruction ⁄ blockage
* use of manual manoeuvres
* \<3 bowel movements per week
* Availability of internet connection
* BMI 20-30
* Male or female
* Willingness to abstain from functional ingredients and such as probiotics, prebiotics and foods containing high amounts of fermentable fibers and laxatives starting 1 month prior to start of the study as well as during the washout period.
Exclusion Criteria
* Drug usage
* Excessive alcohol usage (\>4 consumptions/day or \>20 consumptions/week)
* Pregnancy or lactating
* Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy
* Use of antibiotics within 1 month prior to inclusion
* Vegetarians
* Weight loss \> 5 kg within 1 month prior to inclusion
18 Years
75 Years
ALL
No
Sponsors
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Ingredion Incorporated
INDUSTRY
NIZO Food Research
OTHER
Responsible Party
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Principal Investigators
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Sandra ten Bruggencate, PhD
Role: PRINCIPAL_INVESTIGATOR
NIZO Food Research
Locations
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NIZO food research
Ede, Gelderland, Netherlands
Countries
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Related Links
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Related Info
Other Identifiers
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NL46640.081.14
Identifier Type: -
Identifier Source: org_study_id