Improving Behavior in Children with Autism through Gut Microbiome Therapy: The EMBRACE-ASD Study
Scientific Title of Study
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
Trial Acronym
EMBRACE-ASD
Secondary IDs if Any
Secondary ID
Identifier
IIRPIG-2025-01-01326
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kumari Rina
Designation
Associate Professor
Affiliation
AIIMS Kalyani
Address
Room No 318, Third Floor, Department of Psychiatry, AIIMS Kalyani, NH 34 Connector, Basantapur, Kalyani, Nadia, West Bengal 741245
Nadia WEST BENGAL 741245 India
Phone
9914576444
Fax
Email
drkumaririna@gmail.com
Details of Contact Person Scientific Query
Name
Dr Kumari Rina
Designation
Associate Professor
Affiliation
AIIMS Kalyani
Address
Room No 318, Third Floor, Department of Psychiatry, AIIMS Kalyani, NH 34 Connector, Basantapur, Kalyani, Nadia, West Bengal 741245
Nadia WEST BENGAL 741245 India
Phone
9914576444
Fax
Email
drkumaririna@gmail.com
Details of Contact Person Public Query
Name
Dr Kumari Rina
Designation
Associate Professor
Affiliation
AIIMS Kalyani
Address
Room No 318, Third Floor, Department of Psychiatry, AIIMS Kalyani, NH 34 Connector, Basantapur, Kalyani, Nadia, West Bengal 741245
Nadia WEST BENGAL 741245 India
Phone
9914576444
Fax
Email
drkumaririna@gmail.com
Source of Monetary or Material Support
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029
Primary Sponsor
Name
Indian Council of Medical Research (ICMR)
Address
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Kumari Rina
AIIMS Kalyani
Room No 318, Department of Psychiatry Nadia WEST BENGAL
99145 76444
drkumaririna@gmail.com
Dr Debadatta Mohapatra
AIIMS, Bhubaneswar
Room No 103, First floor, Academic Block Khordha ORISSA
9437658251
psych_debadatta@aiimsbhubaneswar.edu.in
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani
Approved
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Neurotypical children
Patients
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Autogenic graft
n 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. 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 the placebo will use 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.
Intervention
SwasthyaBiome from HNC
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. 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 the placebo will use 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.
Inclusion Criteria
Age From
3.00 Year(s)
Age To
15.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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.
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
42 months
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
20/04/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="4" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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.