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Probiotic supplementation with Bifidobacterium animalis BB-12 in children with functional constipation

Efficacy of Bifidobacterium animalis subsp. lactis BB-12 as a Complementary Therapy for Pediatric Functional Constipation: An Interventional Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605544998967
Enrollment
56
Registered
2026-05-07
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Paediatrics

Interventions

lactulose plus probiotic
lactulose group

Sponsors

armed forces collage of medicine
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Children were included in the study if they fulfilled all of the following criteria: • Age between 4 and 15 years • Both males and females • Diagnosis of functional constipation according to Rome IV criteria • Regular follow-up at the gastroenterology outpatient clinic • Written informed consent obtained from parents or legal guardians

Exclusion criteria

Exclusion criteria: Children were excluded from the study if they had any of the following: • History suggest Organic causes of constipation, including: o Hirschsprung disease o Cystic fibrosis o Neurological disorders o Spinal anomalies o Anatomical anorectal malformations o Metabolic diseases such as hypothyroidism o Irritable bowel syndrome o Intellectual disability o Previous gastrointestinal surgery • Current use of medications affecting gastrointestinal motility • Immunocompromised states • Known hypersensitivity to probiotic components

Design outcomes

Primary

MeasureTime frame
Successful treatment, defined as improvement of signs and symptoms according to Rome IV diagnostic criteria for functional constipation.

Secondary

MeasureTime frame
• Tolerance and palatability • Occurrence of adverse effects

Countries

Egypt

Contacts

Public Contactmohamed elemam

assistant lecturer of pediatrics

mahammedelemam40@gmail.com12345

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026