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Probiotics for treatment of acute childhood diarrhea

Three combination probiotics for treatment of acute childhood diarrhea: an open labelled, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18444252
Enrollment
216
Registered
2018-02-23
Start date
2017-05-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Acute childhood diarrhea Signs and Symptoms

Interventions

The randomized sequence was generated by a person not directly involved in execution of the study. The RAND function of Excel (Microsoft, Redmond, WA, USA) was used to generate computer randomly permu

Sponsors

Infinitus (China) Company Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Infants and children with an episode of mild to moderate acute diarrhea (>4 (semi)watery stools/day according to Bristol criteria (Bristol criteria =6)) lasting more than 12 h and less than 72 h, requiring hospitalization

Exclusion criteria

Exclusion criteria: 1. Subjects with clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit 2. Taking immunosuppressive therapy 3. Known immunodeficiency disorder 4. Pancreatic dysfunction 5. Bloody diarrhea 6. Chronic gastrointestinal disease 7. Short bowel syndrome 8. Bilious or bloody vomitus 9. Probiotics 1 month before admission 10. Severe malnutrition

Design outcomes

Secondary

MeasureTime frame
Number of loose stools per day during the entire episode, measured using an appropriate CRF every day during the intervention

Primary

MeasureTime frame
Duration of diarrhea [time in hours from enrolment to the last abnormal (loose or liquid) stool], measured using an appropriate CRF every day during the intervention

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026