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Effect of scFOS on Increase in Stool Frequency in Constipated People (CONSYST)

S

Syral

Status

Completed

Conditions

Functional Constipation
Healthy

Treatments

Dietary Supplement: scFOS
Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03707002
PEC14513

Details and patient eligibility

About

The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Full description

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.

Enrollment

186 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

186 participants in 2 patient groups, including a placebo group

scFOS
Active Comparator group
Description:
scFOS consumed at 5g/day for 6 weeks
Treatment:
Dietary Supplement: scFOS
Placebo
Placebo Comparator group
Description:
maltodextrin consumed at 5g/day for 6 weeks
Treatment:
Dietary Supplement: Maltodextrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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