CTRI/2022/02/040457招募中未知
A study to define Epigenetic signatures and gut microbiome profiles in Autism Spectrum Disorders (ASD) and assessment of clinical outcomes of Fecal Microbiota Transfer Therapy (FMT) in ASD and investigate the causal association between gut microbiome and development of ASD (Gut Symbiont Restoration Therapy - GSRT)
Providence Microbiome Research Center Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •DONOR INCLUSION CRITERIA
- •1. Both parents of the donors are willing to provide Audio-Video and a written informed consent form.
- •2. Healthy neurotypical children.
- •3. Healthy donors, both boys and girls, inclusive of age 3 to 12 years.
- •4. Children with the same blood group, preferably the same gender, are selected.
- •5. No abnormalities in serological testing.
- •6. No family history of metabolic disorders and autoimmune diseases and cancers Etc.
- •7. No history of usage of antibiotics, antifungals, antivirals, and immunosuppressant in the last three months.
- •8. No gastrointestinal conditions like a history of IBD, IBS, chronic constipation, chronic diarrhea and Celiac disease.
- •9. No active illness.
- •RECIPIENT INCLUSION CRITERIA
- •1. Both parents of the participant are willing to provide Audio-Video and a written informed consent form.
- •2. Patients of both sex boys and girls, inclusive of ages 3 to 17 years, will be enrolled in the study.
- •3. Patients who are diagnosed with non-syndromic autism spectrum disorder (ASD) or other Autism Diagnostic observational Schedule (ADOS) validated ASD diagnosis, diagnosed on modified Checklist for autism in toddlers (M-CHAT) or Childhood autism rating scale
- •(CARS) scoring and confirmed with a neurological examination.
- •4. No recent changes in medication in the last two months.
- •5. Autism with or without gastrointestinal symptoms.
- •6. Autism with epilepsy without frequent seizure episodes.
- •7. Participants within general good health except for autism symptoms and gastrointestinal symptoms, and occasional seizures.
排除标准
- •DONOR EXCLUSION CRITERIA
- •1. Adults, adolescents and children less than 3 yrs.
- •2. Any abnormality on serological testing.
- •3. Any illness acute or chronic.
- •4. Any family history of metabolic syndrome, chronic illness, autoimmune diseases, cancer and mental illness Etc.
- •RECIPIENT EXCLUSION CRITERIA
- •1. Abnormal karyotyping.
- •2. Syndrome patients.
- •3. Cerebral palsy, mental retardation, and global developmental delay
- •4. Known genetic disorders.
- •5. Cardiomyopathies, Congenital Heart Disease.
- •6. Renal failure and liver failure.
- •7. Active illness.
- •8. Age more than 17 years and less than 3 years.
- •9. Immunocompromised or cancers Etc.
- •10. Not willing for consent.
- •11. Shown adverse reaction during test doses.
- •12. Positive for HIV, HbsAg and HCV, other transmittable diseases.
- •13. Recent surgeries or planned surgeries.
- •14. Serious metabolic disorders or hyperbilirubinemia Etc.
- •15. Severe GI problem which requires immediate medical attention or surgery.
- •16. Major brain malformation.
- •17. Bedridden and require complete assistance.
- •18. Hemorrhoids, rectal prolapse, fissures Etc.
- •19. Positive for stool for occult blood.
- •20. Bleeding per rectum, fissures, fistula and with any other abnormality.
- •21. Participation in any interventional clinical study within the past 90 days of enrollment to treatment.
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