infantile colic
Conditions
Sponsors
Wuxi Maternal and Child Health Care Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: (1) Excluding organic pathology, the diagnosis meets the criteria of Rome IV: 1) For the purpose of clinical diagnosis, the following criteria must be met: a. The symptoms began and ended before the baby was 5 months old; b. There was no obvious trigger for prolonged recurrent crying, irritability, or agitation that was difficult for the caregiver to soothe; c. There was no evidence of growth delay, fever, or illness. 2) For the purpose of clinical research, the following three diagnostic criteria must be met, in addition to meeting the two conditions below: a. The investigator conducts a telephone interview or in-person consultation, and the caregiver describes the baby's crying or irritability lasting 3 hours or more per day, at least 3 days per week; b. The baby's crying and irritability lasted for 3 hours or more within 24 hours. (2) Males and females aged 0-5 months; (3) No antibiotic treatment prior to admission; (5) No use of any medication affecting gastrointestinal motility within the past week; (6) All blood, urine, and stool routine tests, as well as liver and kidney function tests, are within normal ranges before treatment; (7) The caregiver completes a written informed consent form, a basic information survey form, and agrees to cooperate with the study throughout the trial period.
Exclusion criteria
Exclusion criteria: (1) Abdominal pain caused by acute abdomen, epileptic abdominal pain, intestinal obstruction, intestinal volvulus, and other diseases; (2) Persistent vomiting; (3) Organic gastrointestinal diseases (inflammatory bowel disease, abdominal cavity diseases, gastrointestinal infections, gastrointestinal hemorrhage, and gastrointestinal tumors, etc.); (4) Co-existing malignant tumors, congenital hereditary diseases, and other diseases; (5) Organic disease (liver, kidney, and heart function failure, diabetes, etc.); (6) The guardian of the trial participant refuses to sign the informed consent form, or the trial participant is estimated to have poor compliance, with poor follow-up compliance; (7) The use of antibiotics, probiotics (yogurt, drinks, etc.), laxatives, and other drugs that may affect intestinal function within 4 weeks before the start of the study; (8) Allergic or intolerant to the components of the experimental probiotic product; (9) Participants who experience adverse reactions or serious adverse reactions, have an emergency situation, are receiving concurrent treatment, or violate the study protocol will be considered to withdraw from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal 16S rDNA sequence;Short chain fatty acids;Inflammatory factors;Neurotransmitters;Immunoglobulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool routine examination;Blood routine examination;Blood biochemical;Faecal calprotectin; | — |
Countries
China
Contacts
Public ContactRenqiang Yu
Wuxi Maternal and Child Health Care Hospital
Outcome results
None listed