Phase 4
N=153
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Functional Constipation
Bottom Line
View on ClinicalTrials.gov: NCT03054805 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. — 0.00486; 0.0000148; 0.00000189 number of bacteria per mg of feces
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Magnesium Oxide (Drug); MIYAIRI-BM (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. |
0.00486; 0.0000148; 0.00000189 | — |
Summary
To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.
Eligibility Criteria
Inclusion Criteria
Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:
- Two or fewer defecations per week.
- At least one episode per week of incontinence after acquiring 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. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month.
Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:
- Two or fewer defecations in the toilet per week.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional 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. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week
Exclusion Criteria
- gastroesophageal reflux disease
- inflammatory bowel disease
- cardiopulmonary diseases
- liver disease
- renal disease
- genetic diseases
- endocrinal diseases
- received abdominal surgeries
Data sourced from ClinicalTrials.gov (NCT03054805). 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.