Functional ConstipationCONSYSTNCT03707002
Effect of scFOS on Increase in Stool Frequency in Constipated People
A study testing scFOS and Maltodextrin in people with Functional Constipation and Healthy, run by Syral at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation, Healthy
- What is being tested?
- scFOS and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
Read the 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.
- Conditions
- Functional Constipation, Healthy
- Being tested
- scFOS, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scFOSDietary supplement
daily intake for 6 weeks
MaltodextrinDietary supplement
daily intake for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| scFOS | Active comparator | scFOS consumed at 5g/day for 6 weeks Receives: Dietary Supplement: scFOS |
| Placebo | Placebo comparator | maltodextrin consumed at 5g/day for 6 weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Change in the number of stool per week between week at Baseline and the last week of supplementation
Measured: 6 weeks
Secondary outcomes (3)
Stool consistency
Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)
Measured: 6 weeks
Frequency and severity of Gastrointestinal symptoms
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
Measured: 6 weeks
Anxiety and depression
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startOct 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syral
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes
- Responsible party
- Sponsor
- Investigators
- David Gendre, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707002
- Sponsor's protocol ID
- PEC14513
- Acronym
- CONSYST
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03707002
- Acronym / sponsor ID
- CONSYST / PEC14513
- Conditions
- Functional Constipation, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- SyralIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scFOS | Active comparator | Dietary Supplement: scFOSscFOS consumed at 5g/day for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrinmaltodextrin consumed at 5g/day for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scFOSdaily intake for 6 weeks | Dietary supplement | scFOS |
| Maltodextrindaily intake for 6 weeks | Dietary supplement | Placebo |
Primary outcome
Stool frequency
Time frame: 6 weeks
Change in the number of stool per week between week at Baseline and the last week of supplementation
3 secondary outcomes
Stool consistency
Time frame: 6 weeks
Frequency and severity of Gastrointestinal symptoms
Time frame: 6 weeks
Anxiety and depression
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gendre, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scFOS and Maltodextrin in people with Functional Constipation and Healthy, run by Syral at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.