A Randomized, Double-Blind, Crossover, Placebo Controlled Trial of Bacillus clausii in Childhood Constipation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200222003

Enrollment

Registered

2020-02-22

Start date

2020-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

&#45

Interventions

patients and caregiver are educated and advised in dietary modification and get stool chart diary&#44

receive bacillus clausii,patients and caregiver are educated and advised in dietary modification and get stool chart diary&#44

receive placebo

Active Comparator Drug,Placebo Comparator Drug

bacillus clausii,placebo

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children who was diagnosed constipation by ROME IV criteria.

Exclusion criteria

Exclusion criteria: Children with suspected or proven organic causes of constipation, use medication causing constipation, receive antibiotic during study, immunocompromised host, neurological impairment and congenital heart disease were excluded

Design outcomes

Primary

Measure	Time frame
stool frequency and consistency 8 week after start protocol stool chart	—

Secondary

Measure	Time frame
abdominal pain, fecal incontinence, painful defecation 8 week after start protocol Patient reported outcome using a questionnaire interview	—

Countries

Thailand

Contacts

Public ContactJirachart Phrommas

Ramathibodhi Hospital

ballmed024@hotmail.com+6622011446

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

A Randomized&#44; Double&#45;Blind&#44; Crossover&#44; Placebo Controlled Trial of Bacillus clausii in Childhood Constipation