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A randomized controlled study of Aunulife probiotics for the adjuvant treatment of diarrhea and constipation in infants

A randomized controlled study of Aunulife probiotics for the adjuvant treatment of diarrhea and constipation in infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056445
Enrollment
Unknown
Registered
2022-02-06
Start date
2022-02-28
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Diarrhea and constipation in infants

Interventions

Intervention for diarrhea:Probiotics for 5 days
Intervention for constipation:Probiotics for 28 days
Control for diarrhea:Placebo for 5 days
Control for constipation:Placebo for 28 days

Sponsors

Xiangya School of Public Health, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Infants aged 3 to 36 months; 2. Diagnosed as diarrhea or constipation in infants; 3. Parents or primary guardians can read and write Chinese; 4. Informed consent of parents or primary guardian. Among them: infant diarrhea: defined as painless defecation >= 3 times a day, and the stool is not formed or liquid stool. Infant constipation: meet at least 2 of the following symptoms, lasting at least 1 month: 1. The number of defecation is less than or equal to 2 times per week; 2. History of massive fecal retention; 3. History of pain and difficulty in defecation; 4. History of fecal discharge; 5. There are a large number of fecal masses in the rectum; The following additional criteria may be used for children who have learned to defecate: 6. Stool incontinence at least once a week after learning to defecate; 7. There is a history of fecal discharge, and it may even cause toilet blockage.

Exclusion criteria

Exclusion criteria: 1. Do not reside locally; 2. With malnutrition, severe dehydration, severe systemic disease (such as encephalitis, sepsis, pneumonia), immunodeficiency, severe liver and kidney function and cardiopulmonary function, an abnormal spirit, food allergies, and other diseases of the digestive system (intestinal malformations, bowel surgery, short bowel syndrome, inflammatory bowel disease, congenital malformation gastrointestinal tract, etc.); 3. Use broad-spectrum antibiotics or any antidiarrheal drugs >= 3 days within 2 weeks before enrollment; 4. Use probiotics and prebiotics before enrollment; 5. Poor medication compliance.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;Infant diarrhea cure rate;Infant constipation cure rate;

Countries

China

Contacts

Public ContactLin Qian

Xiangya School of Public Health, Central South University

linqian@csu.edu.cn+86 13874820173

Outcome results

None listed

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