Infant functional gastrointestinal disease
Conditions
Interventions
Functional diarrhea-Control:Take placebo
Functional diarrhea-CCFM1078:Take CCFM1078
Functional diarrhea-CCFM1269:Take CCFM1269
Functional constipation-Control:Take placebo
Functional constipation-CCFM1078:Take CCFM1078
Functional constipation-CCFM1269:Take CCFM1269
Sponsors
Department of Gastroenterology, Children's Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: Infantile colic 1) Age 0-6 months, gender is not limited; 2) Meet the diagnostic criteria of Roman IV infant colic; 3) No serious metabolic diseases, no serious cardiovascular, cerebrovascular, lung, liver, kidney and other chronic diseases; 4) No clear history of abdominal surgery; 5) The patient's family members have good communication skills and can follow the requirements of the study protocol to complete the records and follow-up. The patient's family members signed informed consent and were willing to participate in the clinical trial. Functional diarrhea 1) Age 6-36 months, gender is not limited; 2) Meet the diagnostic criteria of Rome IV functional diarrhea; 3) No serious metabolic diseases, no serious cardiovascular, cerebrovascular, lung, liver, kidney and other chronic diseases; 4) No clear history of abdominal surgery; 5) The patient's family members have good communication skills and can follow the requirements of the study protocol to complete the records and follow-up. The patient's family members signed informed consent and were willing to participate in the clinical trial. Functional constipation 1) Age 0-36 months, gender is not limited; 2) Meet the diagnostic criteria of Rome IV functional constipation; 3) No drugs affecting gastrointestinal motility and constipation treatment have been used in the past 1 week; 4) No serious metabolic diseases, no serious cardiovascular, cerebrovascular, lung, liver, kidney and other chronic diseases; 5) No clear history of abdominal surgery; 6) The patient's family members have good communication skills and can follow the requirements of the study protocol to complete the records and follow-up. The patient's family members signed informed consent and were willing to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to Bifidobacterium breve CCFM1078 and Bifidobacterium longum CCFM1269 as well as similar drugs or have adverse reactions; 2) acute, chronic and protracted diarrhea; 3) Subjects with adverse reactions or serious adverse reactions, disease emergencies, concomitant treatments, and study protocol violations will be considered for withdrawal from the trial; 4) Organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, gastrointestinal tumors, etc.); 5) Organic diseases (hepatic, kidney, cardiac insufficiency, diabetes, etc.); 6) Long-term abuse of antidiarrheal drugs or systemic corticosteroids 7) The guardian of the subject refuses to sign the informed consent form, or the subject has poor estimated compliance and poor follow-up compliance; 8) Those who have participated in clinical trials of other investigational drugs in the past 12 weeks; 9) Use of antibiotics, probiotics (yogurt, beverages, etc.), laxatives, and other medications that may affect bowel movements within 4 weeks prior to the start of the study.
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;Urine routine examination; | — |
Countries
China
Contacts
Public ContactZhang Ting
Department of Gastroenterology, Children's Hospital of Shanghai
Outcome results
None listed