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The therapeutic effect and potential mechanism of probiotics on functional constipation

The therapeutic effect and potential mechanism of probiotics on functional constipation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032910
Enrollment
Unknown
Registered
2020-05-15
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Functional constipation

Interventions

Placebo group:Placebo
Probiotic group:C. butyricum

Sponsors

Shengjing Hospital Affiliated to China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 3-14 years; 2. Meet the diagnostic criteria of Rome IV functional constipation: For children under 4 years old, at least 2 of these conditions shall be met and the duration shall be 1 month and above: (1) Defecate less than 2 times a week; (2) History of defecation effort and pain during defecation; (3) The history of defecation was rough; (4) * massive fecal retention; (5) A large amount of feces was found in the rectum. If the child has received defecation training, the following two conditions are also available: (6) To be able to control fecal incontinence at least once a week after defecation; (7) Bulky excrement used to clog the toilet. Children over the age of 4 must meet at least two conditions: (1) Defecate in the toilet twice or less every week; (2) Pain or difficulty in defecation; (3) * fecal retention or excessive inhibition of bowel movements. (4) Drain the thick stool to block the toilet; (5) There was a history of incontinence at least once a week; (6) A large amount of feces was found in the rectum.

Exclusion criteria

Exclusion criteria: 1. Those who have used antibiotics within 2 months; 2. Subjects who have used probiotics and prebiotics within 2 months; 3. Subjects who have used corticosteroids or immunosuppressants within 3 months; 4. Patients with or diagnosed with organic and functional gastrointestinal diseases (such as celiac diseases, acute and chronic intestinal diseases, chronic intestinal diseases, inflammatory bowel diseases, intestinal tumors, etc.); 5. Patients with nervous system diseases (such as spina bifida and Hirschsprung's disease); 6. Patients with gastrointestinal malformation and dysplasia; 7. Patients who took cathartic within 4 weeks; 8. Patients taking non steroidal anti-inflammatory drugs and traditional Chinese medicine regularly; 9. Patients who have had extra intestinal surgery.

Design outcomes

Primary

MeasureTime frame
Defecation frequency;

Countries

China

Contacts

Public ContactWu Jie

Shengjing Hospital Affiliated to China Medical University

wujiedoc@163.com+86 18940251108

Outcome results

None listed

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