chronic diarrhea
Conditions
Interventions
Placebo group:Placebo
Bifidobacterium brevis CCFM683 group:500 million bifidobacterium brevis CCFM683
Lactobacillus plantarum CCFM8661 group:500 million Lactobacillus plantarum CCFM8661
Lactobacillus acidophilus CCFM1200 group:500 million Lactobacillus acidophilus CCFM1200
Bifidobacterium brevis CCFM1300 group:500 million bifidobacterium brevis CCFM1300
Bifidobacterium longum infant subspecies CCFM1269:500 million Bifidobacterium longum infant subspecies CCFM1269
Sponsors
Wuxi maternal and Child Health Care Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Consistent with the diagnosis of chronic diarrhea; (2) Male and female (1-12 years old); (3) Exclude organic diseases, meet the following Rome IV standards, and defecate more than or equal to three times a day. Accompanied by at least 2 of the following: 1. Related to bowel movement; 2. Accompanied by changes in the frequency of defecation; 3. Accompanied by changes in fecal characteristics (appearance). (4) According to the Bristol fecal Trait Scale, type 6 and type 7 can be regarded as diarrhea. (5) No drugs affecting gastrointestinal motility have been used in the past week; (6) Good compliance, able to comply with the requirements of clinical trials; (7) The subject or guardian has signed the informed consent; (8) Before treatment, routine blood, urine and stool, liver and kidney function tests were in the normal range. (9) Patients filled in the written informed consent, basic information questionnaire, dietary structure and living conditions questionnaire, and promised to cooperate with the study during the whole experiment period
Exclusion criteria
Exclusion criteria: (1) Severe diarrhea or more severe complex diarrhea symptoms, such as ulcerative or blood-stasis stools, presence of red blood cells or leukin stools requiring antibiotic treatment, and presence of ulcers, were excluded from the study; (2) Participants with adverse or severe adverse reactions, disease emergencies, concomitant treatment and study protocol violations will be considered for withdrawal from the trial; (3) organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, gastrointestinal infections and gastrointestinal tumors, etc.); (4) organic diseases (liver, kidney and heart dysfunction, diabetes, etc.); (5) long-term abuse of antidiarrheal drugs or systemic corticosteroids; (6) Patients refuse to sign the informed consent, or the estimated compliance is poor, and the follow-up compliance is poor; (7) Use antibiotics, probiotics (yogurt, beverages, etc.), laxatives, and other medications that may affect bowel movement within 4 weeks prior to study start; (8) Allergies or intolerances to the ingredients of experimental probiotic products. (9) Other cases that did not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Severity Questionnaire (refer to IBS-SSS);Daily quality of life assessment (refer to IBS-QOL);Fecal flora genomics;Metabolomics of fecal flora;biochemical indices of serum; | — |
Secondary
| Measure | Time frame |
|---|---|
| Height;Weight; | — |
Countries
China
Contacts
Public ContactYu Renqiang
Wuxi Maternal and child Health Care Hospital
Outcome results
None listed