Functional constipation
Conditions
Interventions
Trial group:Dietary fiber composition (Beichangbao), 2 bags daily
Control group:Placebo, 2 bags daily. The placebo contains no active dietary fiber
all other ingredients are identical to those in the experimental group.
Sponsors
Chongqing Health Center for Women and Children
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Meets the Rome IV criteria for the retrospective diagnosis of functional constipation (FC) in children: For patients aged >=4 years, in the absence of irritable bowel syndrome criteria, at least two of the following conditions must be present, occurring at least once per week for at least 1 month: (1) Bowel movements =8 years must also sign the ICF and voluntarily agree to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Children who have been repeatedly treated with conventional medications (e.g., polyethylene glycol, lactulose) and shown no response, as determined by the investigator; 2. Use of any dietary fiber supplement at least 3 times per week over the past 4 weeks; 3. Children with constipation due to potential organic causes, such as intestinal obstruction, Hirschsprung disease, cystic fibrosis, or gastrointestinal malformations; 4. Children with constipation due to significant developmental delay associated with musculoskeletal or neurological disorders that impair gastrointestinal function; 5. Children with constipation secondary to endocrine, metabolic, neurologic, organ, autoimmune diseases, or medications; 6. Underlying conditions: heart disease, hypertension, diabetes; or other serious medical history including, but not limited to, disorders of the nervous, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, or skeletal systems; 7. Children with severe psychiatric disorders (e.g., autism spectrum disorder, bipolar disorder, schizophrenia, severe depression) who are unable to comply with treatment or whose condition may affect treatment response; 8. Use of laxatives or drugs affecting gastrointestinal motility (e.g., opioids, calcium supplements, iron supplements, clonidine, anticholinergics, non-potassium-sparing diuretics) within the past 30 days; 9. Participation in any clinical trial for FC or other investigational drugs within the past 12 weeks; 10. Any other condition deemed unsuitable for enrollment in this clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of stools; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective time of defecation;Remedial drug usage rate;Stool consistency;Vital signs;Pain level;Laboratory and other inspections;Physical examination;Gut microbiota; | — |
Countries
China
Contacts
Public ContactSun Hailan
Chongqing Health Center for Women and Children
Outcome results
None listed