Functional Constipation | Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
Functional Constipation research study
What is the primary objective of this study?
Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore, these dietary non-digestible carbohydrates might relieve functional constipation. 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).
Who is eligible to participate?
Inclusion Criteria: - Age 18-75 yr - 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: - Currently participating in another clinical trial - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:sc-FOS 2g/dayChewing tablets containing Short-chain fructooligosaccharides 2g/day
Dietary Supplement:sc-FOS 4g/dayChewing tablets containing short-chain Fructooligosaccharides 4g/day
Dietary Supplement:sc-FOS 8g/dayChewing tablets containing short-chain Fructooligosaccharides 8g/day
Dietary Supplement:PlaceboChewing tablets without short-chain Fructooligosaccharides
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
sc-FOS 2g/dayPlacebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks)
sc-FOS 4g/dayPlacebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks)
sc-FOS 8g/dayPlacebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks)
Start Date: April 2014
Completed Date: December 2014
Primary Outcome: Stool frequency (Number of complete bowel movements per day)
Secondary Outcome: Stool consistency (Bristol Stool Scale)
Study sponsors, principal investigator, and references
Principal Investigator: Sandra ten Bruggencate, PhD
Lead Sponsor: NIZO Food Research
Collaborator: Ingredion Incorporated