Functional ConstipationNCT01847950
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
A study testing Short-chain fructo-oligosaccharides and Maltodextrin in people with Functional Constipation, 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 constistency 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
- What is being tested?
- Short-chain fructo-oligosaccharides and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Apr 2014
- 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
- subjects with functional constipation
Who cannot join
- subjects treated with laxative treatments
- subjects consuming more than 25g/day of dietary fibres
- pregnant women
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 Fructo-oligosachharides on Increase of Stool Frequency in Constipated People
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation
- Conditions
- Functional Constipation
- Being tested
- Short-chain fructo-oligosaccharides, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-chain fructo-oligosaccharidesDietary supplement
Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| short-chain fructo-oligosaccharides | Experimental | Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks Receives: Dietary Supplement: Short-chain fructo-oligosaccharides |
| Maltodextrin | Placebo comparator | maltodextrins are consummed 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.
Frequency of stool emission
Measured: 6 weeks
Secondary outcomes (1)
Stool consistency (Bristol scale)
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 posted7 May 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionApr 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syral
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Benamouzig, Pr, Principal investigator, CRNH - CRV Avicenne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847950
- Sponsor's protocol ID
- ConstiFOS
- Status last verified
- Oct 2018
- First submitted
- 6 Dec 2012
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 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 Fructo-oligosachharides on Increase of Stool Frequency in Constipated People
- ClinicalTrials.gov ID
- NCT01847950
- Acronym / sponsor ID
- ConstiFOS
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SyralIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 May 2013 (estimated)
- 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 constistency of stools in subjects with functional constipation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-chain fructo-oligosaccharides | Experimental | Dietary Supplement: Short-chain fructo-oligosaccharidesShort-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrinmaltodextrins are consummed 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 (1 listed)
- subjects with functional constipation
Key exclusion criteria (3 listed)
- subjects treated with laxative treatments
- subjects consuming more than 25g/day of dietary fibres
- pregnant women
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 |
|---|---|---|
| Short-chain fructo-oligosaccharidesShort-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks | Dietary supplement | short-chain fructo-oligosaccharides |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Frequency of stool emission
Time frame: 6 weeks
1 secondary outcome
Stool consistency (Bristol scale)
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 5 Oct 2018.
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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.
Robert Benamouzig, Pr principal investigator
CRNH - CRV Avicenne Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-chain fructo-oligosaccharides and Maltodextrin in people with Functional Constipation, 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 1 inclusion and 3 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 5 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?
Frequency of stool emission (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 5 Oct 2018.