ConstipationNCT01985867
Lcr35 for Children With Functional Constipation
A study testing Lactobacillus casei rhamnosus Lcr35 in people with Constipation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Constipation
- What is being tested?
- Lactobacillus casei rhamnosus Lcr35
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children below 5 years of age
- Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:
- Two or fewer defecations per week
- At least 1 episode per week of incontinence after the acquisition of toileting skills
- History of excessive stool retention
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- History of large- diameter stools that may obstruct the toilet
Who cannot join
- Irritable bowel syndrome
- Mental retardation
- Endocrine disease (e.g. hypothyroidism)
- Organic cause of constipation (e.g. Hirschsprung disease)
- Spinal anomalies
- Anatomic defects of the anorectum
Show all 9Show fewer
- History of previous gastrointestinal surgery
- Functional nonretentive fecal incontinence
- Use of drugs that influence gastrointestinal motility
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics, Medical University of Warsaw
Warsaw, 01-184
About this study
Official title: Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.
Read the detailed description
Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.
- Conditions
- Constipation
- Being tested
- Lactobacillus casei rhamnosus Lcr35, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei rhamnosus Lcr35Dietary supplement
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
PlaceboDietary supplement
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus casei rhamnosus Lcr35 | Experimental | Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks Receives: Dietary Supplement: Lactobacillus casei rhamnosus Lcr35 |
| Placebo | Placebo comparator | Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling
Measured: in the fourth week of the intervention
Secondary outcomes (14)
Stool Consistency at Week 4
Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).
For single value median was calculated.
Measured: during fourth week of intervention
Defecation Frequency at Week 4
For single value median was calculated.
Measured: during fourth week of intervention
Fecal Soiling Episodes at Week 4
For single value median was calculated.
Measured: during fourth week of intervention
Number of Defecations That Were Painful at Week 4
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during fourth weeks of intervention
Abdominal Pain at Week 4
Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during fourth weeks of intervention
Number of Participants With Use of Laxatives
Measured: during 4 weeks of intervention
Number of Participants With Adverse Effects
Measured: during 4 weeks of intervention
Stool Consistency at Week 1
Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).
For single value median was calculated.
Measured: during first week of intervention
Defecation Frequency at Week 1
Measured: during first week of intervention
Fecal Soiling Episodes at Week 1
Measured: during first week of intervention
Pain During Defecation at Week 1
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during first weeks of intervention
Abdominal Pain at Week 1
Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during first weeks of intervention
Flatulence at Week 4
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during fourth weeks of intervention
Flatulence at Week 1
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Measured: during first weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Wojtyniak, Medical University of Warsaw
- Investigators
- Hania Szajewska, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985867
- Sponsor's protocol ID
- 1-2013
- Status last verified
- May 2023
- First submitted
- 30 Oct 2013
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wojtyniak K, Horvath A, Dziechciarz P, Szajewska H. Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. J Pediatr. 2017 May;184:101-105.e1. doi: 10.1016/j.jpeds.2017.01.068. Epub 2017 Mar 8.
PubMed 28284477
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
- ClinicalTrials.gov ID
- NCT01985867
- Acronym / sponsor ID
- 1-2013
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 17 May 2023
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 assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.
Detailed description
Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus casei rhamnosus Lcr35 | Experimental | Dietary Supplement: Lactobacillus casei rhamnosus Lcr35Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children below 5 years of age
- Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:
Key exclusion criteria (9 listed)
- Irritable bowel syndrome
- Mental retardation
- Endocrine disease (e.g. hypothyroidism)
- Organic cause of constipation (e.g. Hirschsprung disease)
- Spinal anomalies
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 casei rhamnosus Lcr35Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks) | Dietary supplement | Lactobacillus casei rhamnosus Lcr35 |
| PlaceboEligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling
Time frame: in the fourth week of the intervention
14 secondary outcomes
Stool Consistency at Week 4
Time frame: during fourth week of intervention
Defecation Frequency at Week 4
Time frame: during fourth week of intervention
Fecal Soiling Episodes at Week 4
Time frame: during fourth week of intervention
Number of Defecations That Were Painful at Week 4
Time frame: during fourth weeks of intervention
Abdominal Pain at Week 4
Time frame: during fourth weeks of intervention
Number of Participants With Use of Laxatives
Time frame: during 4 weeks of intervention
Number of Participants With Adverse Effects
Time frame: during 4 weeks of intervention
Stool Consistency at Week 1
Time frame: during first week of intervention
Defecation Frequency at Week 1
Time frame: during first week of intervention
Fecal Soiling Episodes at Week 1
Time frame: during first week of intervention
Pain During Defecation at Week 1
Time frame: during first weeks of intervention
Abdominal Pain at Week 1
Time frame: during first weeks of intervention
Flatulence at Week 4
Time frame: during fourth weeks of intervention
Flatulence at Week 1
Time frame: during first weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28284477Wojtyniak K, Horvath A, Dziechciarz P, Szajewska H. Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. J Pediatr. 2017 May;184:101-105.e1. doi: 10.1016/j.jpeds.2017.01.068. Epub 2017 Mar 8.
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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.
Hania Szajewska, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei rhamnosus Lcr35 in people with Constipation, run by Medical University of Warsaw 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 8 inclusion and 9 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 17 May 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling (time frame: in the fourth week of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01985867, which also lists 1 linked publication.
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 17 May 2023.