Infantile colic and functional constipation
Conditions
Interventions
Intestinal colic - Positive control group:Take simethicone tablets
Intestinal colic - Low-dose CCFM1078:Take CCFM1078 at a dose of 2.5×109CFU per day
Intestinal colic - High-dose CCFM1078:Take CCFM1078 at a dose of 5×109CFU per day
Intestinal colic - Low-dose CCFM1269:Take CCFM1269 at a dose of 2.5×109CFU per day
Intestinal colic - High-dose CCFM1269:Take CCFM1269 at a dose of 5×109CFU per day
Functional constipation - Positive control group:Take lactulose
Functional constipation - low-dose CCFM1078:Take CCFM1078 at a dose of 2.5×109CFU per day
Functional constipation - High-dose CCFM1078:Take CCFM1078 at a dose of 5×109CFU per day
Functional constipation - low-dose CCFM1269:Take CCFM269 at a dose of 2.5×109CFU per day
Functional constipation - High-dose CCFM1269:Take CCFM1269 at a dose of 5×109CFU per day
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: Infantile colic 1. Age 0-6 months, gender not limited; 2. Meets the diagnostic criteria for infantile colic as defined by Rome IV; 3. Has no severe metabolic diseases, no serious chronic diseases such as heart, brain, lung, liver, or kidney diseases; 4. Has no history of abdominal surgery; 5. The patient's family members have good communication skills and can follow the requirements of the research plan to complete records and follow-up. The patient's family members sign the informed consent form and are willing to participate in this clinical trial. Functional constipation; 1. Age: 0 - 36 months, Gender: No restrictions; 2. Meets the diagnostic criteria of Rome IV functional constipation; 3. In the past 1 week, no medications that affect gastrointestinal motility or treat constipation have been used; 4. No severe metabolic diseases, no serious chronic diseases such as heart, brain, lung, liver, or kidney 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 research plan to complete records and follow-up. The patient's family members sign the informed consent form and are willing to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic or have adverse reactions to Bifidobacterium breve CCFM1078, Bifidobacterium longum CCFM1269, talc, lactulose, and similar drugs; 2. Chronic diarrhea and persistent diarrhea; 3. Subjects with adverse reactions or severe adverse reactions in emergency situations, those with contraindications to treatment and research protocols, and those who violate the study protocol will be considered to withdraw from the trial; 4. Organic gastrointestinal diseases (inflammatory bowel disease, abdominal diseases, gastrointestinal tumors, etc.); 5. Organic diseases (liver and kidney dysfunction, 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 is estimated to have poor compliance, or those with poor follow-up compliance; 8. Those who have participated in other clinical trials of investigational drugs within the past 12 weeks; 9. Within 4 weeks before the start of the study, the subject used antibiotics, probiotics (yogurt, beverages, etc.), laxatives, and other drugs that may affect defecation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Assessment Scale;Sleep rating scale;Fecal morphology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal 16S rDNA sequence;Stool routine examination;Blood routine examination;Urine routine examination;Fecal metabolome;Urine metabolome;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactLin Zhou
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed