| CTRI Number |
CTRI/2020/10/028322 [Registered on: 09/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Evaluation of the clinical Outcome of Beta Glucan & Nano ECF (Entro-Coccus Faecalis) in Children with ASD (Autism spectrum disorders) |
|
Scientific Title of Study
|
Evaluating the benefits of Beta Glucan & Nano ECF (Entro-Coccus Faecalis) in children with ASD (Autism spectrum disorders) by analysis of gut microbiota
and related parameters |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavan Kadalraja |
| Address |
Department of Paediatric Neurology,
Door No: 17, Vinyagar Nagar,
Opposite. District court, K.K Nagar,
Madurai - 625 020
Madurai
TAMIL NADU
625020
India |
| Phone |
9840301991 |
| Fax |
|
| Email |
drkragavan27@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Raghavan Kadalraja |
| Address |
Department of Paediatric Neurology,
Door No: 17, Vinyagar Nagar,
Opposite. District court, K.K Nagar,
Madurai - 625 020
TAMIL NADU
625020
India |
| Phone |
9840301991 |
| Fax |
|
| Email |
drkragavan27@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Raghavan Kadalraja |
| Address |
Department of Paediatric Neurology,
Door No: 17, Vinyagar Nagar,
Opposite. District court, K.K Nagar,
Madurai - 625 020
TAMIL NADU
625020
India |
| Phone |
9840301991 |
| Fax |
|
| Email |
drkragavan27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kenmax Medical Service Private Limited
Door No: 17, Vinyagar Nagar,
Opposite. District court, K.K Nagar,
Madurai - 625 020.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Medi Nippon Health Care Private Limited MDN |
| Address |
B6, 13, Zakariah Colony III Street,
Choolaimedu,
Chennai – 600094
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raghavan Kadalraja |
Kenmax Medical Service Private Limited |
Department of Paediatric Neurology,
Door No: 17, Vinyagar Nagar, Opposite. District court, K.K Nagar, Madurai - 625 020
Madurai
|
9840301991
drkragavan27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saravana Multispeciality Hospital-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Childhood disorder of social functioning, unspecified |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bifilac in pediatric dose |
Control arm with Bifilac |
| Intervention |
ECF (Gumi biotic) |
1gram of ECF (Gumi biotic) per day for 84 days |
| Intervention |
Nichi glucan |
1gram of nichi glucan per day for 84 days |
| Intervention |
Nichi glucan and ECF (Gumi biotic) |
1 gram each of Nichi glucan and ECF (Gumi biotic) |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged less than 18 years
2. Both male and female
3. ASD criteria as per CARS (Childhood Autism Rating Scale) score
4. Parents willing to consent for their children for actively participating in the study |
|
| ExclusionCriteria |
| Details |
1. Subjects aged more than 18 years old
2. Any child with acute general illness or is on any antibiotic, anti-inflammatory, or antioxidant treatment for the last two weeks
3. Hyperallergic to any of the investigational products
4. Subjects with long standing infections |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) change in the Childhood Autism Rating Scale Score and behavioral change in the subjects at the end of 12 weeks
2)Evaluation of Fecal samples for DNA extraction, PCR of 16S rRNA V3 Region and Sequencing pre and post treatment in all 4 groups
3) Evaluation of Fecal samples for pH and Serotonin levels before and at the end of study in all the groups
4) Assessment of synaptic activity before and after study in all groups through evaluation of serum synuclein levels
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events will be recorded and analysed |
adverse events will be reported as and when it occurs through telephonic conversation. further, subjects will be questioned during their visits on day 28, 56, 84 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Brief Summary
|
Recent research
suggests, besides neurological pathology, the dysbiosis in gut and the
disruption in gut-brain axis is emerging as a prominent factor leading to ASD.
Changes in the gut microbiota composition can lead to general systemic and
central nervous system inflammation. Dietary supplementation of Yeast has been
observed to treat dysbiosis effectively . One such yeast is Nichi Glucan
(β-glucans). β-glucans are the glucose polymers present in the cell walls of
yeast. β-glucans have earlier been
reported to have significant impact on the gut microbiota changes influencing
positive health. β-glucans function as a prebiotic fiber thereby modulating the
human gut microbiota. And furthermore, emerging research indicates a
beneficiary effect of ECF (Entro-Coccus Faecalis) as a Biological response
modifier (BRM) that have a wide range of beneficial effects particularly
anti-inflammatory in nature in the gut. The main objectives of the study is,
To compare and evaluate the efficacy of Nichi glucan and Nano ECF in comparison to standard treatment for outcomes related to clinical behavior in children with ASD (Autism spectrum disorders) by analysis of gut microbiota and its related parameters To evaluate safety of Beta Glucan & Nano ECF (Entro-Coccus Faecalis) by recording the adverse events Evaluation of Fecal samples for DNA extraction, PCR of 16S rRNA V3 Region and Sequencing pre and post treatment in all 4 groups Evaluation of Fecal samples for pH and Serotonin levels before and at the end of study in all the groups Assessment of synaptic activity before and after study in all groups through evaluation of serum synuclein levels
|
