Phase 4
Completed N=153
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Source: ClinicalTrials.gov NCT03054805 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.