Functional ConstipationPhase 4NCT01388712
Lactobacillus Reuteri in Children With Constipation
A Phase 4 study testing Lactobacillus reuteri DSM 17938 in people with Functional Constipation, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
Trial summary
The most common cause of children chronic constipation is functional disorders. Functional constipation is diagnosed after excluding organic causes of constipation (anatomical, neurological, endocrinological) and identification of two symptoms defined by the Rome III criteria. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 4
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 3-7 years old
- Occurrence less than three bowel movement per week
- Medical history from at least two months]
- Ineffective laxative treatment at least two months
- The parents approval for child participation in the study and for the treatment
Who cannot join
- Well-known, organic cause of constipation (i.e. hypothyroidism, Hirschprung disease, cystis fibrosis)
- Anatomic defects of the alimentary canal
- The surgery of the alimentary canal in the past
- Treatment of antibiotics/probiotics during last two weeks before start of the study
Trial locations and contacts
1 site in 1 country.
Jaroslaw Kierkus, Ph.D. contact
Poland1 site, 1 recruiting
- Recruiting
ChildrensMHIPoland
Warsaw, 04-730
Jaroslaw Kierkus, Ph.D., +48 228157384
About this study
Official title: The Assessment of Lactobacillus Reuteri Efficacy, Provided With Forlax, as Treatment of Incurable Constipation in Children 3-7 Years. Double Blind, Placebo-controlled, Randomized and Multicenter Trial
The most common cause of children chronic constipation is functional disorders. Functional constipation is diagnosed after excluding organic causes of constipation (anatomical, neurological, endocrinological) and identification of two symptoms defined by the Rome III criteria. There could be low number of bowel movements (below three times a week), defecation pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter stools. The treatment is change of diet, defecation training and application of laxatives.
The probiotics are defined as living microorganisms, which provided in a proper doses should result in beneficial effect on a host health. The assessment of its characteristic is related to strain of bacteria affiliation.
Read more
Taking into the consideration that patients with constipation may experience microflora intestine disorders, using the probiotics can have the positive impact on process of treating this disease. The additional reason for using the probiotics during the constipation treatment is an influence of probiotics on movement of the alimentary canal.
In spite of proved effectiveness of some probiotics' strains further research are required, because clinical significance is ambiguous and the effect is confirmed among patients with short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM 17938, which was successful treatment method of chronic constipation amongst children (infants) should be performed.
The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy, provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The baseline of estimation is the frequency comparison of bowel movement in children belonging into two groups: Lactobacillus reuteri treatment and placebo.
The secondary aim of the study is the assessment of frequency the additional symptoms connected with defecation disorders: such as: number of pain episodes during defecation, the intensity of pain, number of hard stools, number of fecal incontinence per week, number of macrogol (Forlax) pockets used.
The investigators believe that constipation treatment (laxatives- macrogol) with Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus reuteri in 3-7 years old children with medical history of chronic constipation.
- Conditions
- Functional Constipation
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo
- Keywords
- Probiotics, constipation, children
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
Patients, who met inclusion criteria, will receive following medicaments during 8 weeks: Lactobacillus reuteri DSM 17938 in form of chewing (one tablets containing 10^8CFU).
PlaceboDietary supplement
Patients, who met inclusion criteria, will receive an identical to probiotic looking and tasting placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Probiotics | Active comparator | Lactobacillus reuteri DSM 17938 Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bowel movement per week, without fecal incontinence
Measured: 12 weeks
Secondary outcomes (6)
The number of bowel movements per week
Other secondary items are: the number of pain episodes during defecation per week, the number of hard stools, the number of fecal incontinence per week, the number of patients who have to change amount of drug or use of enema.
Measured: 12 weeks
The number of pain episodes during defecation per week,
Measured: 12 weeks
The number of hard stools
Measured: 12 weeks
The number of fecal incontinence per week
Measured: 12 weeks
The number of patients who have to change amount of drug
Measured: 12 weeks
The number of patients who have to change use of enema.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012 (estimated)
- Study completionDec 2012 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
- Investigators
- Jaroslaw Kierkus, Ph.D., Study chair, Children's Memorial Health Institute, PolandAgnieszka Wegner, M.D., Principal investigator, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388712
- Sponsor's protocol ID
- CZDGA23.01.2011
- Status last verified
- Apr 2012
- First submitted
- 5 Jul 2011
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Lactobacillus Reuteri Efficacy, Provided With Forlax, as Treatment of Incurable Constipation in Children 3-7 Years. Double Blind, Placebo-controlled, Randomized and Multicenter Trial
- ClinicalTrials.gov ID
- NCT01388712
- Acronym / sponsor ID
- CZDGA23.01.2011
- Conditions
- Functional Constipation
- Keywords
- Probiotics, constipation, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Jul 2011 (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 most common cause of children chronic constipation is functional disorders. Functional constipation is diagnosed after excluding organic causes of constipation (anatomical, neurological, endocrinological) and identification of two symptoms defined by the Rome III criteria. There could be low number of bowel movements (below three times a week), defecation pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter stools. The treatment is change of diet, defecation training and application of laxatives.
The probiotics are defined as living microorganisms, which provided in a proper doses should result in beneficial effect on a host health. The assessment of its characteristic is related to strain of bacteria affiliation.
Taking into the consideration that patients with constipation may experience microflora intestine disorders, using the probiotics can have the positive impact on process of treating this disease. The additional reason for using the probiotics during the constipation treatment is an influence of probiotics on movement of the alimentary canal.
In spite of proved effectiveness of some probiotics' strains further research are required, because clinical significance is ambiguous and the effect is confirmed among patients with short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM 17938, which was successful treatment method of chronic constipation amongst children (infants) should be performed.
The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy, provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The baseline of estimation is the frequency comparison of bowel movement in children belonging into two groups: Lactobacillus reuteri treatment and placebo.
The secondary aim of the study is the assessment of frequency the additional symptoms connected with defecation disorders: such as: number of pain episodes during defecation, the intensity of pain, number of hard stools, number of fecal incontinence per week, number of macrogol (Forlax) pockets used.
The investigators believe that constipation treatment (laxatives- macrogol) with Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus reuteri in 3-7 years old children with medical history of chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Probiotics | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 17938Lactobacillus reuteri DSM 17938 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 3-7 years old
- Occurrence less than three bowel movement per week
- Medical history from at least two months]
- Ineffective laxative treatment at least two months
- The parents approval for child participation in the study and for the treatment
Key exclusion criteria (4 listed)
- Well-known, organic cause of constipation (i.e. hypothyroidism, Hirschprung disease, cystis fibrosis)
- Anatomic defects of the alimentary canal
- The surgery of the alimentary canal in the past
- Treatment of antibiotics/probiotics during last two weeks before start of the study
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 |
|---|---|---|
| Lactobacillus reuteri DSM 17938Patients, who met inclusion criteria, will receive following medicaments during 8 weeks: Lactobacillus reuteri DSM 17938 in form of chewing (one tablets containing 10^8CFU). | Dietary supplement | Probiotics |
| PlaceboPatients, who met inclusion criteria, will receive an identical to probiotic looking and tasting placebo. | Dietary supplement | Placebo |
Primary outcome
Number of bowel movement per week, without fecal incontinence
Time frame: 12 weeks
6 secondary outcomes
The number of bowel movements per week
Time frame: 12 weeks
The number of pain episodes during defecation per week,
Time frame: 12 weeks
The number of hard stools
Time frame: 12 weeks
The number of fecal incontinence per week
Time frame: 12 weeks
The number of patients who have to change amount of drug
Time frame: 12 weeks
The number of patients who have to change use of enema.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
Related trials for Functional Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
Functional Constipation
Active, not recruiting
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Constipation, Constipation - Functional
Recruiting
Fiber Nutritional Supplement for Management of Constipation During Pregnancy
Functional Constipation (FC)
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.
Jaroslaw Kierkus, Ph.D. contact
Jaroslaw Kierkus, Ph.D. study chair
Children's Memorial Health Institute, Poland
Agnieszka Wegner, M.D. principal investigator
Children's Memorial Health Institute, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus reuteri DSM 17938 in people with Functional Constipation, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
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 4 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 3 Apr 2012. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jaroslaw Kierkus, Ph.D. (+48 228157384), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bowel movement per week, without fecal incontinence (time frame: 12 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 3 Apr 2012; AzTrials last refreshed its copy on 4 Nov 2026.