Functional ConstipationNCT03333070
The Use of Lactobacillus Reuteri in Functional Constipation in Children
A study testing probiotic - Lactobacillus reuteri in people with Functional Constipation, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic… Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- probiotic - Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Jun 2018to 26 Jun 2018
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0.5 - 15 years
- Diagnosis of functional constipation according to Rome IV criteria
Who cannot join
- Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction.
- Prematurity (< 34 weeks)
- S/P intestinal surgery
- Children treated with medications associated with constipation.
- Existing malignancy
- Primary or secondary immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Lactobacillus Reuteri in Functional Constipation in Children: A Double Blind Randomized Control Trial
Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.
Read the detailed description
Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.However, it is unclear whether similar effects occur in children. Lactobacilli and Bifidobacteria are the most studied species showing a high safety profile. Both are able to promote colonic peristalsis which could be beneficial for the treatment of constipation .Even though traditional treatment is well established and safe, high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG .Lactobacilli, bifidobacteria and FOS (fructooligosaccharide) increase stool frequency and decrease consistency in healthy adults and therefore could prevent recurrence of constipation after PEG withdrawal .The principle investigator hypothesize that treatment with probiotics adjunct to PEG and several months thereafter could decrease the proportion of children needed permanent or prolonged treatment (>12 months) with PEG.
The importance of the study and its practical benefits:
Treatment with PEG for FC is well established and is considered safe. Despite that, a high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG. Previous studies did not demonstrate efficacy of treatment with probiotics or prebiotics in FC. Neither of these studies assessed effectiveness probiotics/prebiotic products as adjunct to the traditional treatment (PEG) of FC in shortening its period.
A recently published studies including from Israel, demonstrated efficacy of Lactobacillus reuteri in irritable bowel syndrome, infantile colic and functional abdominal pain .Therefore, demonstration of positive effect of treatment with probiotic product in FC, could imply for potential use of this product in other functional gastrointestinal disorders among children.
- Conditions
- Functional Constipation
- Being tested
- probiotic - Lactobacillus reuteri, placebo - with no active ingredient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic - Lactobacillus reuteriDietary supplement
The treated arm will receive 5 drops per day for 48 weeks
placebo - with no active ingredientOther
The control arm will receive 5 drops per day for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | 25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of ~1g/kg/day) for 12 weeks.
After 12 weeks of treatment they will be randomized: treated arm will receive probiotic containing Lactobacillus reuteri for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks Receives: Dietary Supplement: probiotic - Lactobacillus reuteri |
| Placebo Arm | Placebo comparator | 25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of ~1g/kg/day) for 12 weeks.
After 12 weeks of treatment they will be randomized: control arm will receive placebo for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks Receives: Other: placebo - with no active ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of constipation recurrence
according to Rome IV criteria
Measured: This measure will be assessed at weeks 24.
The prevalence of constipation recurrence
according to Rome IV criteria
Measured: This measure will be assessed at weeks 60.
failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment
according to Rome IV criteria
Measured: This measure will be assessed at weeks 24.
failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment
according to Rome IV criteria
Measured: This measure will be assessed at weeks 60.
Secondary outcomes (3)
The number of bowel movements per week
The investigator will collect the information during the following visits from the patient
Measured: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
The number of episodes of fecal incontinence per week
The investigator will collect the information during the following visits from the patient
Measured: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
The stool consistency in patients without PEG treatment
The investigator will collect the information during the following visits from the patient
Measured: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start26 Jun 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Why it stopped: The PI was ended her work in the hospital and no replacement was found.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarit Peleg, HaEmek Medical Center, Israel
- Investigators
- Sarit Peleg, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333070
- Sponsor's protocol ID
- 0042-17-EMC
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lactobacillus Reuteri in Functional Constipation in Children: A Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03333070
- Acronym / sponsor ID
- 0042-17-EMC
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI was ended her work in the hospital and no replacement was found.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 6 Nov 2017 (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.
Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.
Detailed description
Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.However, it is unclear whether similar effects occur in children. Lactobacilli and Bifidobacteria are the most studied species showing a high safety profile. Both are able to promote colonic peristalsis which could be beneficial for the treatment of constipation .Even though traditional treatment is well established and safe, high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG .Lactobacilli, bifidobacteria and FOS (fructooligosaccharide) increase stool frequency and decrease consistency in healthy adults and therefore could prevent recurrence of constipation after PEG withdrawal .The principle investigator hypothesize that treatment with probiotics adjunct to PEG and several months thereafter could decrease the proportion of children needed permanent or prolonged treatment (>12 months) with PEG.
The importance of the study and its practical benefits:
Treatment with PEG for FC is well established and is considered safe. Despite that, a high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG. Previous studies did not demonstrate efficacy of treatment with probiotics or prebiotics in FC. Neither of these studies assessed effectiveness probiotics/prebiotic products as adjunct to the traditional treatment (PEG) of FC in shortening its period.
A recently published studies including from Israel, demonstrated efficacy of Lactobacillus reuteri in irritable bowel syndrome, infantile colic and functional abdominal pain .Therefore, demonstration of positive effect of treatment with probiotic product in FC, could imply for potential use of this product in other functional gastrointestinal disorders among children.
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 |
|---|---|---|
| Treatment Arm | Active comparator | Dietary Supplement: probiotic - Lactobacillus reuteri25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of ~1g/kg/day) for 12 weeks. After 12 weeks of treatment they will be randomized: treated arm will receive probiotic containing Lactobacillus reuteri for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks |
| Placebo Arm | Placebo comparator | Other: placebo - with no active ingredient25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of ~1g/kg/day) for 12 weeks. After 12 weeks of treatment they will be randomized: control arm will receive placebo for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0.5 - 15 years
- Diagnosis of functional constipation according to Rome IV criteria
Key exclusion criteria (6 listed)
- Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction.
- Prematurity (< 34 weeks)
- S/P intestinal surgery
- Children treated with medications associated with constipation.
- Existing malignancy
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 |
|---|---|---|
| probiotic - Lactobacillus reuteriThe treated arm will receive 5 drops per day for 48 weeks | Dietary supplement | Treatment Arm |
| placebo - with no active ingredientThe control arm will receive 5 drops per day for 48 weeks | Other | Placebo Arm |
Primary outcome
The prevalence of constipation recurrence
Time frame: This measure will be assessed at weeks 24.
according to Rome IV criteria
The prevalence of constipation recurrence
Time frame: This measure will be assessed at weeks 60.
according to Rome IV criteria
failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment
Time frame: This measure will be assessed at weeks 24.
according to Rome IV criteria
failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment
Time frame: This measure will be assessed at weeks 60.
according to Rome IV criteria
3 secondary outcomes
The number of bowel movements per week
Time frame: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
The number of episodes of fecal incontinence per week
Time frame: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
The stool consistency in patients without PEG treatment
Time frame: This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
Results and safety
The study was stopped early (reason given: The PI was ended her work in the hospital and no replacement was found.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, 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
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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.
Sarit Peleg, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic - Lactobacillus reuteri in people with Functional Constipation, run by HaEmek Medical Center, Israel at 1 site 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 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: stopped early, as of the sponsor's last update on 4 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 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?
The study was stopped early (reason given: The PI was ended her work in the hospital and no replacement was found.). Results are not available in the source record.
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?
The prevalence of constipation recurrence (time frame: This measure will be assessed at weeks 24.). The study lists 4 primary outcomes in all. 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 4 Oct 2018.