Chronic abdominal diarrhea and pain in infants and young children
Conditions
Interventions
Diarrhea-Control:Take placebo
Diarrhea-CCFM683:Take CCFM683
Diarrhea-CCFM1269:Take CCFM1269
Abdominal pain - Control:Take placebo
Abdominal pain-CCFM683:Take CCFM683
Abdominal pain-CCFM1269:Take CCFM1269
Sponsors
Wuxi Second People's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1 Chronic diarrhea (1) Compliant with diagnosis of chronic diarrhea: Diarrhea lasting more than two weeks; (2) Male and female (0-3 years old); (3) Excluding organic lesions, meeting the following Roman IV criteria, with a bowel frequency greater than or equal to three times a day. Accompanied by at least 2 of the following: a Related to defecation; b. Accompanied by changes in bowel frequency; c. Accompanied by changes in fecal characteristics (appearance). (4) According to the Bristol Fecal Trait Scale, diarrhea can be classified as type 6 (pasty) and type 7 (watery stool). (5) Not using any medication that affects gastrointestinal motility in the past week; (6) Before treatment, routine blood, urine, and stool tests, as well as liver and kidney function tests, were all within the normal range. (7) The guardian fills out a written informed consent form and basic information survey form, and promises to cooperate with the research throughout the entire experimental period. 2 Chronic abdominal pain (1) Meets the diagnostic criteria for functional abdominal pain, irritable bowel syndrome, or infantile colic Diagnostic criteria for functional abdominal pain: According to the Rome IV criteria, this disease belongs to FAP-NOS (Functional Abdominal Pain Non Other Specific Indications), equivalent to FAP and Functional Abdominal Pain Syndrome (FAPs) in Rome III diagnosis. FAP diagnostic criteria: At least 2 months prior to diagnosis, symptoms meet the following conditions and abdominal pain occurs at least 4 times per month: a. Episodic or persistent abdominal pain, not entirely related to physiological events (such as eating or menstruation); b. Not meeting the diagnostic criteria for irritable bowel syndrome (IBS) and functional dyspepsia (FD); c. After appropriate evaluation, abdominal pain cannot be explained by other diseases. Diagnostic criteria for irritable bowel syndrome: recurrent abdominal pain, occurring at least once or more per week within the past 3 months, accompanied by 2 or more of the following: a. Related to defecation; b. Accompanied by changes in bowel frequency; c. Symptoms accompanied by changes in fecal characteristics (appearance) have appeared for at least 6 months before diagnosis, and in the past 3 months, the following are the IBS-D classification criteria: IBS-D:>1/4 (25%) of bowel movements are Bristol fecal type 6 or 7, and<1/4 (25%) of bowel movements are Bristol fecal type 1 or 2. d. Children with constipation will not experience pain relief as constipation improves (if pain relief occurs, it is functional constipation rather than IBS); e. After appropriate evaluation, the symptoms cannot be fully explained by other diseases. Diagnostic criteria for infantile colic: For the purpose of clinical diagnosis, it is necessary to meet: a. Infants<5 months old at the onset and cessation of symptoms; b. Long term repeated crying, irritability, or irritability without obvious cause, difficult for the guardian to soothe; c. There is no evidence of growth retardation, fever, or illness. For the purpose of clinical research, the above three diagnostic criteria must be met, while also meeting the following two conditions: a. Researchers conduct phone conversations or face-to-face consultations, and guardians describe babies crying or being agitated for 3 hours or more per day, at least 3 days or more per week; b. Crying and irritability lasting for 3 hours or more within 24 hours. (2) Male and female (0-3 years old); (3)
Exclusion criteria
Exclusion criteria: (1) Severe diarrhea or more severe and complex symptoms of diarrhea and abdominal pain, such as ulcerative or blood stasis stools, presence of red blood or white blood cell count stools, requiring antibiotic treatment, and presence of ulcers, were excluded from the study; (2) Subjects with adverse reactions or serious adverse reactions, emergency medical conditions, concomitant treatment, and violation of the study protocol will be considered for withdrawal from the trial; (3) Organic gastrointestinal diseases (inflammatory bowel disease, abdominal disease, gastrointestinal infections, and gastrointestinal tumors, etc.); (4) Organic diseases (liver, kidney and heart dysfunction, diabetes, etc.); (5) Long term abuse of antidiarrheals or systemic corticosteroids; (6) Patients who refuse to sign informed consent forms, or have poor estimated compliance or poor follow-up compliance; (7) Use antibiotics, probiotics (yogurt, beverages, etc.), laxatives, and other medications that may affect bowel movements within 4 weeks prior to the start of the study; (8) Allergy or intolerance to the ingredients of experimental probiotic products.
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 ContactQiaoqin Chen
Wuxi Second People's Hospital
Outcome results
None listed