NCT02140749

Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults

Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Short-chain Fructooligosaccharides on Stool Frequency in Constipated Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: NIZO Food Research · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sc-FOS 2g/day	Chewing tablets containing Short-chain fructooligosaccharides 2g/day
DIETARY_SUPPLEMENT	sc-FOS 4g/day	Chewing tablets containing short-chain Fructooligosaccharides 4g/day
DIETARY_SUPPLEMENT	sc-FOS 8g/day	Chewing tablets containing short-chain Fructooligosaccharides 8g/day
DIETARY_SUPPLEMENT	Placebo	Chewing tablets without short-chain Fructooligosaccharides

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-05-16
• Last updated: 2015-12-11

Locations

1 site across 1 country: Netherlands