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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707002

Acronym

CONSYST

Enrollment

186

Registered

2018-10-16

Start date

2015-10-31

Completion date

2017-01-31

Last updated

2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation, Healthy

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTscFOS

daily intake for 6 weeks

DIETARY_SUPPLEMENTMaltodextrin

daily intake for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Identical sachets containing 5g of scFOS or placebo (maltodextrins)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Stool frequency	6 weeks	Change in the number of stool per week between week at Baseline and the last week of supplementation

Secondary

Measure	Time frame	Description
Stool consistency	6 weeks	Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)
Frequency and severity of Gastrointestinal symptoms	6 weeks	Change in the frequency (number of occurrence) and severity (Likert scores from 0= no symptom to 7 =severe symptoms) individual Gastro-Intestinal symptoms (bloating, abdominal pain, flatulence,...) between Baseline and the end of supplementation
Anxiety and depression	6 weeks	Changes in anxiety and depression score between Baseline and the end of supplementation, measured by HAD score (Zigmond et al, 1983, from 0 to 21, score above 11 = anxiety or depression related pathology

Other

Measure	Time frame	Description
Heart rate	at baseline and at the last visit (after 6 weeks)	heart rate (bit per minute)
systolic blood pressure	at baseline and at the last visit (after 6 weeks)	systolic blood pressure (mmHg)
diastolic blood pressure	at baseline and at the last visit (after 6 weeks)	diastolic blood pressure (mmHg)
Adverse event	6 weeks	Registration of all adverse events (number and severity of events)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026