The effect of probiotics on functional constipation in childre

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0004155
• Lead Sponsor: Koera University Guro Hospital

Brief Summary

Overall, 187 children were assigned to the lactulose monotherapy (n = 69), combination therapy (n = 68), or S. boulardii monotherapy (n = 50) groups. The primary outcome was significantly higher in the lactulose monotherapy group (26.1%) or combination therapy group (41.2%) than in the S. boulardii monotherapy group (8.0%). The S. boulardii monotherapy group showed a significantly lower cumulative successful maintenance and drug maintenance rate than the other 2 groups. There were no significant intergroup differences in the frequency of defecation, incontinence, painful defecation, or stool consistency during the follow-up at week 2.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-31
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

The patients aged from 6 month to 6 years and fulfill the Rome IV criteria will be included in this study.
Must include 1 month of at least 2 of the following in infants up to 4 years of age:
1. 2 or fewer defecations per week
2. History of excessive stool retention
3. History of painful or hard bowel movements
4. History of large-diameter stools
5. Presence of a large fecal mass in the rectum
In toilet-trained children, the following additional criteria may be used:
6. At least 1 episode/week of incontinence after the acquisition of toileting skills
7. History of large-diameter stools that may obstruct the toilet
Must include 2 or more of the following occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome:
1. 2 or fewer defecations in the toilet per week in a child of a developmental age of at least 4 year
2. At least 1 episode of fecal incontinence per week
3. History of retentive posturing or excessive volitional stool retention
4. History of painful or hard bowel movements
5. Presence of a large fecal mass in the rectum
6. History of large diameter stools that can obstruct the toilet

Exclusion Criteria

Children with organic causes of constipation such as Hirschsprung’s disease, spinal bifida (occulta), hypothyroidism or other metabolic or renal abnormalities, mental retardation, and children using drugs (e.g. calcium channel blockers, antidysrhythmic agents, anticonvulsants, antidepressants, anticholinergic agents) influencing gastrointestinal function other than laxatives were excluded.
The patients have been taking probiotics or lactulose steadily for more than 2 weeks.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatment success rate (defecation > 3 episodes per weeks without soiling)

Secondary Outcome Measures

Name	Time	Method
treatment change rate;pain during defecation;dose of lactulose;Bristol scale;adverse reaction;episode of defecation;soiling