Functional ConstipationNCT01913665
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
A study testing B.lactis, Inulin and B.Lactis +Inulin in people with Functional Constipation, run by Eskisehir Osmangazi University.
Trial summary
The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- B.lactis, Inulin and B.Lactis +Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with functional constipation over 3 years age
- below 18 years of age
Who cannot join
- Chronic gastrointestinal disease,
- hirschsprung disease,
- celiac disease,
- hypothyroids,
- neurological deficit,
- constipation treatment receiving children will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children
- Conditions
- Functional Constipation
- Being tested
- B.lactis, Inulin, B.Lactis +Inulin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B.lactisOther
InulinOther
B.Lactis +InulinOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| B.Lactis | Active comparator | children with functional constipation Receives: Other: B.lactis |
| Inulin | Active comparator | children with functional constipation Receives: Other: Inulin |
| B.Lactis+ınulin | Active comparator | children with functional constipation Receives: Other: B.Lactis +Inulin |
| plasebo | Placebo comparator | children with functional constipation Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare defecation frequency between baseline and 4 th week of treatment
Measured: baseline and 4th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makbule Eren, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913665
- Sponsor's protocol ID
- not defined yet
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
- ClinicalTrials.gov ID
- NCT01913665
- Acronym / sponsor ID
- not defined yet
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 1 Aug 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 aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B.Lactis | Active comparator | Other: B.lactischildren with functional constipation |
| Inulin | Active comparator | Other: Inulinchildren with functional constipation |
| B.Lactis+ınulin | Active comparator | Other: B.Lactis +Inulinchildren with functional constipation |
| plasebo | Placebo comparator | Other: Placebochildren with functional constipation |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children with functional constipation over 3 years age
- below 18 years of age
Key exclusion criteria (6 listed)
- Chronic gastrointestinal disease,
- hirschsprung disease,
- celiac disease,
- hypothyroids,
- neurological deficit,
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 |
|---|---|---|
| B.lactis | Other | B.Lactis |
| Inulin | Other | Inulin |
| B.Lactis +Inulin | Other | B.Lactis+ınulin |
| Placebo | Other | plasebo |
Primary outcome
to compare defecation frequency between baseline and 4 th week of treatment
Time frame: baseline and 4th week of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing B.lactis, Inulin and B.Lactis +Inulin in people with Functional Constipation, run by Eskisehir Osmangazi University.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makbule Eren, Associate professor (00902222392979 ext. 2763,2750,2716, makbule99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare defecation frequency between baseline and 4 th week of treatment (time frame: baseline and 4th week of intervention). 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 7 Aug 2013.