Efficacy of Fecal Microbiota Transplantation Therapy through SwasthyaBiome on Behavioral Symptoms among Children with Autism Spectrum Disorder: A Multicenter Randomized Double-Blind Placebo controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Short (upto 12 weeks) and long term (upto 24 weeks) efficacy of SwasthyaBiome in the behavioral symptoms in C-ASD as measured by ISAA, BSFS and P-GSAT.
研究概览
简要总结
FMT is a promising therapy for alleviating behavioral symptoms in ASD. First multi-center (AIIMS Kalyani and AIIMS Bhubaneswar), DB-RCT to investigate the efficacy, safety, and tolerability of SwasthyaBiome among Indian C-ASD, with the objective to examine the efficacy, safety, and tolerability of SwasthyaBiome over 24 weeks among C-ASD. C-ASD and investigators will be blind. Project technical support-III will be unblinded. A written informed consent and assent will be obtained.In Phase-1, 50-cases and 50-matched controls (age- and gender-matched), aged 3-15 years, randomized 1:1, will be recruited from two centers. Metagenomic sequencing will analyze fecal microbiota differences between C-ASD and HNC, extending an ongoing funded study. Super-donors will be selected through rigorous HNC screening. In Phase-2, super-donor stool will be standardized into a 60 mg/ml fecal bacterial solution (‘SwasthyaBiome’), while placebo using autogenic-fecal samples. In Phase-3, ISAA, VSMS, BSFS and P-GSAT will be administered. C-ASD will undergo bowel-cleanse with a 5-day-Vancomycin (10mg/Kg/dose, 6-hourly/day)-Rifaximin (200mg, 8-hourly), Polyethylene glycol-lavage (2-days pre-FMT), and overnight fasting. Cases will receive SwasthyaBiome (10g/50kg per child), while controls will get autogenic-FMT via colonoscopy under sedation. All C-ASD will receive FMT on weeks 0, 4, 8, and 12. Safety and tolerability will be monitored from -5 days to 24 weeks on a checklist, while efficacy via ISAA scores, BSFS and P-GSAT at 4, 12 (short-term), and 24 (long-term) weeks. In Phase-4, periodically collected fecal microbiota will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed ASD by a psychiatrist or pediatrician and a psychologist as per DSM-5 and or ICD-11 A score of above 70 on Indian Scale for Autism Assessment Children aged 3 to 15 years Either gender Any gastrointestinal symptoms at presentation, like constipation, diarrhea, abdominal bloating, dyspepsia, etc.
- •Those parents who can understand the concept of the study, are consenting to participate as per the detail study methodology, including, inpatient admission, bowel cleanse procedure, colonoscopy, follow up visits and periodic telephonic calls.
排除标准
- •Children with a history of brain injury, encephalitis, cerebral palsy, neuroleptic malignant syndrome, or other organic brain diseases.
- •Children with fever have a reliance on tube feeding and accompanying emergent gastrointestinal disease that needs prompt medication.
- •Diagnosed with severe malnutrition, body mass index below 10th percentile, body mass index above 90th percentile, excessive weight loss, or severe immunodeficiency diseases.
- •Children with a history of severe allergies, monogenic diseases, mental disorders, or depression.
- •Family history of chronic conditions or autoimmune diseases Children who are undergoing or have undergone synthetic prebiotics or probiotics treatment in the last 1 month or are planned for in the next 6 months.
- •Children who had consumed antibiotics in last 3 months.
- •Underwent FMT in last 12 months.
- •Renal insufficiency and hepatic dysfunction, for example, alanine aminotransferase level more than 1.5 times the normal upper limits, aspartate aminotransferase level more than 1.5 times the normal upper limits, or serum creatinine level more than 1.5 times the normal upper limits.
- •Children with significant medical problems hindering participation Parent suffering from a severe mental illness or medical illness, hindering participation.
结局指标
主要结局
Short (upto 12 weeks) and long term (upto 24 weeks) efficacy of SwasthyaBiome in the behavioral symptoms in C-ASD as measured by ISAA, BSFS and P-GSAT.
时间窗: 42 months
ii. Short (upto 12 weeks) and long term (upto 24 weeks) efficacy of SwasthyaBiome in the behavioral symptoms in C-ASD as measured by ISAA, BSFS and P-GSAT
时间窗: 42 months
次要结局
- i. Establishment of difference in the gut microbiota composition among Indian C-ASD and HNC.(18 months)
- iii. Establishment of safety and tolerability (upto 24 weeks) of SwasthyaBiome in Indian C-ASD.(42 months)
- iv. Difference in the short and long-term gut microbiota of C-ASD post-SwasthyaBiome transplantation.(42 months)
研究者
Dr Kumari Rina
AIIMS Kalyani