Constipation
Conditions
Interventions
Long Bifidobacterium CECT7894 probiotics drops:Bifidobacterium longum CECT7894 probiotic drops: 6 drops per time, once a day
Bifidobacterium longum CECT7894 probiotic drops and lactulose oral solution:Bifidobacterium longum CECT7894 probiotic drops: 6 drops per time, once a day
lactulose oral solution: 5mL each time, once a day.
Control group:Lactulose oral solution: 5mL each time, once a day
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1) According to the Rome IV diagnostic criteria, at least two of the following symptoms should be included for at least 1 month: ? Bowel movement =2 times per week; ? had a history of fecal retention. ? History of painful or difficult bowel movements; ? history of large bowel movements; ? presence of large bowel movements in the rectum. At least one episode of incontinence per week when defecation was controlled; Pass large stools that may block the toilet; 2) Full-term infants with a gestational age of 37 to 42 weeks; 3) birth weight between 2500 g and 4000g; 4) aged 0-3 years; 5) parents voluntarily delay major changes in infant feeding practices; 6) Parents are willing and able to fill in the diaries and questionnaires; 7) sign the informed consent form in person; 8) valid regular visits were available during the trial.
Exclusion criteria
Exclusion criteria: 1) chronic diseases or major medical problems; 2) organic gastrointestinal diseases; 3) growth retardation; 4) use of antibiotics by the breastfeeding mother or by the child within 2 weeks before randomization and during the trial; 5) infants (in formula or in additives) or their mothers, received probiotics within 2 weeks before randomization and during the trial; 6) have participated in other clinical trials; 7) constipation caused by food allergy (such as milk, eggs and other foods).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bowel movements per week;Bristol stool trait score;Discharge of dry stool frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of Bristol stool trait score;Visual analogue Scale (VAS) was used to measure parents' perception of children's defecation difficulty;The VAS measures parent-to-parent/family QOL;VAS was used to measure parental satisfaction;Conspicuous effective number;Number of effective persons;Number of invalid persons; | — |
Countries
China
Contacts
Public ContactQingya Tang
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed