Functional constipation in infants
Conditions
Interventions
group 1:Give Bifidobacterium longum CECT7894 probiotic drops, 6 drops/time, shake well and take it once a day, orally in the morning.
group 2:Give Bifidobacterium longum CECT7894 probiotic drops, 6 drops/time, once a day
and lactulose oral liquid (contains 0.667g lactulose per 1ml) 5ml/time, once a day.
Control group:Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day
Sponsors
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month: (1) Defecation <= 2 times per week; (2) have a history of fecal retention; (3) There is a history of pain or difficulty in defecation; (4) There is a history of expelling large pieces of feces; (5) There is a large fecal mass in the rectum. At least 1 episode of incontinence per week after self-control of bowel movements; passing large pieces of stool that may clog the toilet; 2. Term infants, gestational age from 37 to 42 weeks; 3. Birth weight between 2500 – 4000g; 4.0-3 years old; 5. Parents voluntarily defer major changes in infant feeding practices; 6. Parents are willing and able to fill in diaries and questionnaires; 7. Written signed parental informed consent; 8. Periodic and effective visits can be made during the trial period.
Exclusion criteria
Exclusion criteria: 1. Chronic diseases or major medical problems; 2. Gastrointestinal organic diseases; 3. Growth retardation; 4. The mother or child of the breastfeeding child used antibiotics within 2 weeks before randomization and during the trial; 5. Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial; 6. Has participated in other clinical trials; 7. Food allergies cause constipation (such as milk, eggs and other foods); 8. Withdrawal: Subjects need to withdraw from the trial for the following special reasons: (1) Withdrawal from the agreement: The parents unanimously request to withdraw from the agreement. The doctor should try to understand the reasons as much as possible; (2) Failure to comply with the requirements: The parents were repeatedly unable to complete the test requirements, such as: administration, visits; or feeding formula milk containing any probiotics to infants; or administering any probiotics to infants; breastfeeding mothers taking Probiotics; proton pump inhibitors or antibiotics, etc. given to the baby; (3) Adverse events: Due to the occurrence of adverse events, the responsible physician decided to discontinue participation in the trial. Cases withdrawn for this reason need to be reported on the case report form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency and character;Fecal microbiota;Body height;Body weight;Gastrointestinal Symptoms; | — |
Countries
China
Contacts
Public ContactFeng Yi
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed