Functional constipation
Conditions
Interventions
Blank control group:Lifestyle guidance
Probiotics intervention group:Live Combined Bifidobacterium,Lactobacillus and Enterococcus
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
4 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4-14 years old; 2. Meet the Rome IV standards of the functional constipation for children and adolescents: Must include 2 or more of the following occurring at least once per week for a minimum of 1 month: 1) 2 or fewer defecations in the toilet per week; 2) At least 1 episode of fecal incontinence per week; 3) History of retentive posturing or excessive volitional stool retention; 4) History of painful or hard bowel movements; 5) Presence of a large fecal mass in the rectum; 6) History of large diameter stools that can obstruct the toilet; After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
Exclusion criteria
Exclusion criteria: 1. The study subjects have diseases that may cause changes in their bowel movements , such as history of gastrointestinal surgery, acute and chronic gastroenteritis, acute and chronic pancreatitis, hypothyroidism etc. 2. Allergic to Bifico powder/capsules. 3. Children with severe primary diseases such as cardiovascular, Central nervous system and haematological diseases; 4, Children with mental disorders and unclear discourse; 5, Children who have participated in other clinical trials within the previous 12 weeks; 6. According to the researcher's judgment, other conditions which may reduce the possibility of enrollment or complicate the enrollment, such as unstable living environment and inconvenient transportation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semi-quantitative score of abdominal symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| 16S rRNA Sequencing for stool microotganism;Targeted metabolomics analysis for detection of intestinal microbial metabolites; | — |
Countries
China
Contacts
Public ContactChundi Xu
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed