Trial | NCT03707002  Report issue

Title

Effect of scFOS on Increase in Stool Frequency in Constipated People
Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    186
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
Study Started
Oct 31
2015
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Last Update
Oct 16
2018

Dietary Supplement scFOS

daily intake for 6 weeks

Dietary Supplement Maltodextrin

daily intake for 6 weeks

scFOS Active Comparator

scFOS consumed at 5g/day for 6 weeks

  • Dietary Supplement scFOS

Placebo Placebo Comparator

maltodextrin consumed at 5g/day for 6 weeks

Criteria 

Inclusion Criteria:

functional constipation according to ROME III criteria with 3 or less than 3 stools per week
BMI between 18 and 32kg/m², limits included
Subjects who do not usually eat high-fibre foods
Subjects who do not usually consume foods siad "reduced in sugars" or "light"
Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements

Exclusion Criteria:

subjects presenting Irritable bowel syndrome
history of chronic GI disorders: crohn disease, ulcerative colitis,....
treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)
Antibiotic therapy in progress or in the past 8 weeks
medical history with impact on the study objectives as defined by investigator
known food allergy to one of the compounds of the study product
No Results Posted