N/A
N=94
Lcr35 for Children With Functional Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01985867 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling — 24; 28 Participants — p=0.399
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lactobacillus casei rhamnosus Lcr35 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Medical University of Warsaw
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling |
24; 28 | 0.399 |
| SECONDARY Stool Consistency at Week 4 |
3.5; 3.7 | 0.589 |
| SECONDARY Defecation Frequency at Week 4 |
4.0; 6.0 | 0.005 sig |
| SECONDARY Fecal Soiling Episodes at Week 4 |
0.0; 0.0 | 0.659 |
| SECONDARY Number of Defecations That Were Painful at Week 4 |
0.0; 0.0 | 0.790 |
| SECONDARY Abdominal Pain at Week 4 |
0.0; 0.0 | 0.698 |
| SECONDARY Number of Participants With Use of Laxatives |
18; 10 | 0.120 |
| SECONDARY Number of Participants With Adverse Effects |
0; 3 | 0.116 |
| SECONDARY Stool Consistency at Week 1 |
3.6; 3.9 | 0.612 |
| SECONDARY Defecation Frequency at Week 1 |
5.0; 6.0 | 0.004 sig |
| SECONDARY Fecal Soiling Episodes at Week 1 |
0.0; 0.0 | 0.708 |
| SECONDARY Pain During Defecation at Week 1 |
0.0; 0.0 | 0.522 |
| SECONDARY Abdominal Pain at Week 1 |
0.0; 0.0 | 0.185 |
| SECONDARY Flatulence at Week 4 |
0.0; 0.0 | 0.973 |
| SECONDARY Flatulence at Week 1 |
0.0; 0.0 | 0.642 |
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.
Eligibility Criteria
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:
- 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
Exclusion Criteria
- 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
- History of previous gastrointestinal surgery
- Functional nonretentive fecal incontinence
- Use of drugs that influence gastrointestinal motility
Data sourced from ClinicalTrials.gov (NCT01985867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.