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The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus casei rhamnosus Lcr35 | Dietary Supplement | Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling | in the fourth week of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during fourth week of intervention |
| Defecation Frequency at Week 4 |
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Inclusion Criteria:
Children below 5 years of age
Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hania Szajewska, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Medical University of Warsaw | Warsaw | 01-184 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28284477 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus Casei Rhamnosus Lcr35 | Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks) |
| FG001 | Placebo | Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Casei Rhamnosus Lcr35 | Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling | Posted | Count of Participants | Participants | in the fourth week of the intervention |
|
during 4 weeks of the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Casei Rhamnosus Lcr35 | Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| change in the stool smell | Gastrointestinal disorders | Non-systematic Assessment |
Children were recruited in an academic center specialized in the management of children with constipation. Outcomes were evaluated only based on non-validated stool diaries completed by caregivers, except for stool consistency.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Wojtyniak | The Medical University of Warsaw | +48 22 317 94 21 | wojtyniakkasia@gmail.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks |
|
For single value median was calculated. |
| during fourth week of intervention |
| Fecal Soiling Episodes at Week 4 | For single value median was calculated. | 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. | 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. | during fourth weeks of intervention |
| Number of Participants With Use of Laxatives | during 4 weeks of intervention |
| Number of Participants With Adverse Effects | 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. | during first week of intervention |
| Defecation Frequency at Week 1 | during first week of intervention |
| Fecal Soiling Episodes at Week 1 | 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. | 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. | 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. | 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. | during first weeks of intervention |
| Lack of Efficacy |
|
| Placebo |
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| month |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age of onset of constipation | Mean | Standard Deviation | months |
|
| Duration of constipation | Mean | Standard Deviation | months |
|
| Stools per week | Mean | Standard Deviation | Stools per week |
|
| Stool consistency, Bristol scale | The 7-point Bristol Stool Form Scale (BSFS), which refers to 7 pictures of different forms of stool, is a commonly used instrument to assess stool consistency. Bristol Stool Form Scale: Type 1- Separate hard lumps, like nute (hard to pass); Type 2- Sausage- shaped but lumpy; Type 3- Like a sausage but with cracks on the surface; Type 4- Like a sausage or snake, smooth and soft; Type 5- Soft blobs with clear-cut edges; Type 6- Fluffy pieces with ragged edges, a mushy stool; Type 7- Watery, no solid pieces. Entirely Liquid. | Mean | Standard Deviation | units on a scale |
|
| Fecal soiling | Count of Participants | Participants |
|
| Pain during defecation | Count of Participants | Participants |
|
| Withholding behavior | Parents assess witholding behaviour like rock back and forth while stiffening buttocks and legs, arch back, cross legs, stand on tiptoes, and wriggle or fidget, or squat or get into other unusual positions. | Count of Participants | Participants |
|
| Abdominal pain | Count of Participants | Participants |
|
| Blood in the stool | Count of Participants | Participants |
|
| Previous treatment for intestinal constipation | Count of Participants | Participants |
|
| Rectal impaction | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | during fourth week of intervention |
|
|
|
|
| Secondary | Defecation Frequency at Week 4 | For single value median was calculated. | Posted | Median | Inter-Quartile Range | defecations per week | during fourth week of intervention |
|
|
|
|
| Secondary | Fecal Soiling Episodes at Week 4 | For single value median was calculated. | Posted | Median | Inter-Quartile Range | fecal soiling episodes | during fourth week of intervention |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | painful defecations | during fourth weeks of intervention |
|
|
|
|
| Secondary | Abdominal Pain at Week 4 | Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated. | Posted | Median | Inter-Quartile Range | abdominal pain episodes | during fourth weeks of intervention |
|
|
|
|
| Secondary | Number of Participants With Use of Laxatives | Posted | Count of Participants | Participants | during 4 weeks of intervention |
|
|
|
|
| Secondary | Number of Participants With Adverse Effects | Posted | Count of Participants | Participants | during 4 weeks of intervention |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | during first week of intervention |
|
|
|
|
| Secondary | Defecation Frequency at Week 1 | Posted | Median | Inter-Quartile Range | defecations per week | during first week of intervention |
|
|
|
|
| Secondary | Fecal Soiling Episodes at Week 1 | Posted | Median | Inter-Quartile Range | fecal soiling episodes | during first week of intervention |
|
|
|
|
| Secondary | Pain During Defecation at Week 1 | Pain reported by child or symptoms of pain observed by parents. For single value median was calculated. | Posted | Median | Inter-Quartile Range | painful defecations | during first weeks of intervention |
|
|
|
|
| Secondary | Abdominal Pain at Week 1 | Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated. | Posted | Median | Inter-Quartile Range | abdominal pain episodes | during first weeks of intervention |
|
|
|
|
| Secondary | Flatulence at Week 4 | Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated. | Posted | Median | Inter-Quartile Range | episodes of flatulence | during fourth weeks of intervention |
|
|
|
|
| Secondary | Flatulence at Week 1 | Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated. | Posted | Median | Inter-Quartile Range | episodes of flatulence | during first weeks of intervention |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Placebo | Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks | 0 | 46 | 3 | 46 |
| abdominal pain and flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| loss of appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
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