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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR202103110010

Enrollment

Registered

2021-03-11

Start date

2021-02-01

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

Functional constipation age 1-5 years constipation, children, probiotics.

Interventions

Probiotics,Sterile water (as placebo, tasteless, odorless)

Experimental Drug,Experimental No treatment

Bacillus clausii,Placebo

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children age 1-5 years with constipation according to ROME IV criteria at Ramathibodi hospital

Exclusion criteria

Exclusion criteria: Organic causes of constipation, receive medication causing constipation, immune deficiency, severe neurological or cardiac anomalies

Design outcomes

Primary

Measure	Time frame
Good stooling 4 weeks Bristol stool scale, frequency of stools	—

Secondary

Measure	Time frame
Use of enema 4 weeks Times used	—

Countries

Thailand

Contacts

Public ContactPornthep Tanpowpong

Faculty of Medicine, Ramathibodi Hospital

pornthep.tan@mahidol.ac.th022011446

Outcome results

None listed

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