ConstipationNCT01629147
Treatment of Chronic Constipation in Children With Lactobacillus Reuteri
A study testing Biogaia in people with Constipation, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Constipation
- What is being tested?
- Biogaia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2014to Sep 2016
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the GI tract, with parents agreeing to participate in the study and signing an informed consent.
- Chronic constipation defined by the Rome III criteria (Must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS: 1. Two or fewer defecations in the toilet per week. 2. At least 1 episode of fecal incontinence per week. 3. History of retentive posturing or excessive volitional stool retention. 4. History of painful or hard bowel movements. 5. Presence of a large fecal mass in the rectum. 6. History of large diameter stools that may obstruct the toilet).
- Normal Thyroid function test and negative celiac serology (IgA or IgG in patients with IgA deficiency), and no evidence of elevated RAST test for milk.
- Parents or tutors signed informed consent to the child's participation the study.
- Willingness to comply with the protocol.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Sheba medical center
Ramat Gan, Tel Hashomer, 52625
Batia Weiss, MD, 972526666315, weissb@sheba.health.gov.il
Batia Weiss, MD
Asaf Harofe medical center
Zrifin
Efrat Broide, MD, efibroide@yahoo.com
About this study
Official title: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial
Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.
Read the detailed description
Functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. Constipation is defined by the Rome III criteria. The symptoms are difficult to treat in part of the patients and cause frustration to the patient and family.
Probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. A recent study revealed that the administration of Lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation.
The study goal is to evaluate Lactobacillus reuteri (Biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of Lactobacillus reuteri (Biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.
- Conditions
- Constipation
- Being tested
- Biogaia, Placebo
- Keywords
- Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiogaiaDietary supplement
5 drops containing Lactobacillus reuteri Protectis
PlaceboOther
5 drops
| Study group | Role | What they receive |
|---|---|---|
| Biogaia | Experimental | 5 drops containing Lactobacillus reuteri Protectis Receives: Dietary Supplement: Biogaia |
| Placebo | Placebo comparator | - 5 drops identical in appearance and taste Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in stool number/week to at least 4 bowel movements
The measurement will be done by phone interview at week 1 and 3, and at clinic visits at week 2 and 4.
A follow-up phone interview after the medication/placebo is stopped, at weeks 6 and 8 post enrolment.
Measured: 8 weeks
Secondary outcomes (2)
Improved stool consistency- measured by Bristol Stool Scale
Measured: 4 weeks
Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.
Measured: 4 -8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Principal investigator, Batia Weiss, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629147
- Sponsor's protocol ID
- SHEBA-11-8960-BW-CTIL
- Status last verified
- May 2014
- First submitted
- 24 Jun 2012
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01629147
- Acronym / sponsor ID
- SHEBA-11-8960-BW-CTIL
- Conditions
- Constipation
- Keywords
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 27 Jun 2012 (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.
Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.
Detailed description
Functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. Constipation is defined by the Rome III criteria. The symptoms are difficult to treat in part of the patients and cause frustration to the patient and family.
Probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. A recent study revealed that the administration of Lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation.
The study goal is to evaluate Lactobacillus reuteri (Biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of Lactobacillus reuteri (Biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biogaia | Experimental | Dietary Supplement: Biogaia5 drops containing Lactobacillus reuteri Protectis |
| Placebo | Placebo comparator | Other: Placebo- 5 drops identical in appearance and taste |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the GI tract, with parents agreeing to participate in the study and signing an informed consent.
- Chronic constipation defined by the Rome III criteria (Must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS: 1. Two or fewer defecations in the toilet per week. 2. At least 1 episode of fecal incontinence per week. 3. History of retentive posturing or excessive volitional stool retention. 4. History of painful or hard bowel movements. 5. Presence of a large fecal mass in the rectum. 6. History of large diameter stools that may obstruct the toilet).
- Normal Thyroid function test and negative celiac serology (IgA or IgG in patients with IgA deficiency), and no evidence of elevated RAST test for milk.
- Parents or tutors signed informed consent to the child's participation the study.
- Willingness to comply with the protocol.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biogaia5 drops containing Lactobacillus reuteri Protectis | Dietary supplement | Biogaia |
| Placebo5 drops | Other | Placebo |
Primary outcome
Increase in stool number/week to at least 4 bowel movements
Time frame: 8 weeks
The measurement will be done by phone interview at week 1 and 3, and at clinic visits at week 2 and 4. A follow-up phone interview after the medication/placebo is stopped, at weeks 6 and 8 post enrolment.
2 secondary outcomes
Improved stool consistency- measured by Bristol Stool Scale
Time frame: 4 weeks
Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.
Time frame: 4 -8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biogaia in people with Constipation, run by Sheba Medical Center at 2 sites in Israel.
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 0 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Batia Weiss, MD (972526666315, weissb@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in stool number/week to at least 4 bowel movements (time frame: 8 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 22 May 2014.