Fecal Microbiota Transfer Therapy for Autism
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2022/02/040457
- Lead Sponsor
- Providence Microbiome Research Center Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint <br/ ><br>1) Neurological Improvements will be confirmed with CARS scoring done once every Six Months after Treatment. <br/ ><br>2) Assessment of safety and efficacy of FMT <br/ ><br>3) Childhood Autism Rating Scale (CARS) [Time Frame: change in score from baseline Day -7 or visit no 1 to week 24, week 48, week 72, week 96 at periodic intervals] <br/ ><br>4) A trained evaluator will evaluate the participant child, the range is 15-60, and scores in the range of 30-60 indicate autism.Timepoint: Time Frame: change in score from baseline Day -7 or visit no 1 to week 24, week 48, week 72, week 96 at periodic intervals
- Secondary Outcome Measures
Name Time Method Secondary Endpoint <br/ ><br>1) Both Donor and Recipient are tested for 16s rRNA sequencing with a stool sample to define their Microbiome profiles. <br/ ><br>2) Both donor and recipient are tested for transcriptomic over and under expression of mRNA splicing patterns of pre mRNA etc.Differential expression of microRNA , long noncoding RNA etc. <br/ ><br>3) Both the tests mentioned above will be repeated for the recipient six months after treatment. <br/ ><br>4) A comparative analysis is done to determine changes in microbiome profiles and changes in epigenetic signatures of the recipient after FMT to evaluate the causal association between microbiome and epigenetics. Followed by clinical Correlation to confirm the safety and efficacy of FMT in alleviating core symptoms of ASD and GI symptoms <br/ ><br>Timepoint: Time Frame: change in score from baseline Day -7 or visit no 1 to week 24, week 48, week 72, week 96 at periodic intervals