Autism spectrum disorder in children, periodic vomiting in children, anorexia in children with malnutrition
Conditions
Interventions
Autism Spectrum Disorders:Fecal microbiota transplantation
Cyclic Vomiting Syndrome (CVS):Fecal microbiota transplantation
Anorexia with malnutrition:Fecal microbiota transplantation
Sponsors
Shenzhen Children’s Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. CVS Inclusion criteria: (1)Children below 18 years. (2)The occurrence of 2 or more periods of intense, unremitting nausea and paroxysmal vomiting, lasting hours to days within a 6-month period. (3) Episodes are stereotypical in each patient. (4)Episodes are separated by weeks to months with a return to baseline health between episodes. 2. Anorexia with malnutrition Inclusion criteria: (1) Children with poor appetite, restriction of intake, limited food variety, or fear of eating. (2) Inability to consume enough food to meet nutritional needs for more than 3 months. (3) Diagnosis of malnutrition based on WHO criteria, with weight-for-age and/or height-for-weight Z score <-2SD. (4) No underlying diseases. (5)Aged 1-16 years. 3.Autism Spectrum Disorder (ASD) Inclusion criteria: (1) Aged 3-16 years, no limitation of gender. (2) Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the American Psychiatric Association (see below). (3) With diarrhea, constipation, abdominal bloating, and/or food allergy/intolerance, for at least 6 months and occurring in the past 3 months. (4) Informed consent signed by children's guardians, with agreement of participation in the clinical trial and provision of clinical information, as well as samples of peripheral blood, saliva, urine, feces, and tissues. 4. Healthy donors Inclusion criteria: (1)Age under 18 years; (2) Informed consent obtained from children's guardians; (3) Guardians agree to provide the collection of clinical data and samples including peripheral blood, urine, feces, and tissues.
Exclusion criteria
Exclusion criteria: 1.CVS Exclusion criteria: Exclude vomiting caused by known organic diseases of the digestive system, nervous system, urinary system, metabolic diseases, and endocrine system diseases. 2.Anorexia with malnutrition Satisfying any one of the following conditions: (1) Children with underlying diseases, such as liver or kidney dysfunction, gastrointestinal malformations, congenital, genetic, or metabolic diseases, autoimmune diseases or immunodeficiencies, active tuberculosis, inflammatory bowel disease, chronic lung disease, malignancy, or post major surgery. (2) Neurotic anorexia. (3) Antibiotic or probiotic used in the last one month prior to enrollment. 3.ASD Exclusion criteria: (1) Dagnosis of Rett syndrome (RTT). (2) History of brain diseases, e.g traumatic brain injury, cerebral palsy, encephalitis, etc. (3) Definite diagnosis of other mental illnesses. (4) Intestinal diseases, e.g congenital megacolon, intestinal obstruction, intestinal intussusception, etc. (5) Pathological intestinal inflammation, e.g inflammatory bowel disease. (6) Severe obesity or malnutrition. (7) Some drugs such as probiotics or antibiotics which will affect the gut microbiota were used in the past 3 months or will be used within the next 6 months. (8) Received FMT treatment in the past 12 months. 4.Healthy donors Exclusion criteria: (1) the presence of chronic gastritis, peptic ulcer, inflammatory bowel disease, long-term vomiting or diarrhea; (2) exclude periodic vomiting, anorexia with malnutrition, and autism; (3) Those who are excluded from major liver and kidney diseases, blood system diseases, and nervous system diseases; (4) There is a planned use of probiotics, antibiotics, etc. in the past 3 months or in the next 6 months to affect the intestinal flora
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Species and quantity of fecal bacteria;Disease prognosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;feces routine examination;urine routine;stool culture;liver function;renal function; | — |
Countries
China
Contacts
Public ContactDongling Dai
Shenzhen Children’s Hospital
Outcome results
None listed