| CTRI Number |
CTRI/2025/01/079295 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring the Benefits of Probiotics on Behavior and Gut Health in Children with Autism |
|
Scientific Title of Study
|
Probiotic-Lactobacillus rhamnosus GG Supplementation on Behavior, Quality of Life, and Gut Microbiome Composition in Children with Autism Spectrum Disorder: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murchana Khound |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
AIIMS Guwahati, Department of Pediatrics, changsari, Assam
Kamrup
ASSAM
781101
India |
| Phone |
9954508268 |
| Fax |
|
| Email |
murchana12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murchana Khound |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
AIIMS Guwahati, Department of Pediatrics, changsari, Assam
ASSAM
781101
India |
| Phone |
9954508268 |
| Fax |
|
| Email |
murchana12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Murchana Khound |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
AIIMS Guwahati, Department of Pediatrics, changsari, Assam
ASSAM
781101
India |
| Phone |
9954508268 |
| Fax |
|
| Email |
murchana12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR)
Ansari Nagar,
Post Box No. 4911,
New Delhi - 110029,
India |
|
|
Primary Sponsor
|
| Name |
AIIMS Guwahati |
| Address |
All India Institute of Medical Sciences (AIIMS), Guwahati
Changsari, Kamrup, Assam, India
PIN Code: 781101 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research ICMR |
Indian Council of Medical Research (ICMR)
Ansari Nagar,
Post Box No. 4911,
New Delhi - 110029,
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Murchana Khound |
AIIMS Guwahati |
Room No 1013, First floor, Pediatrics OPD , AIIMS Guwahati
Kamrup
ASSAM |
9954508268
murchana12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F80-F89||Pervasive and specific developmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Probiotic - Lactobacillus rhamnosus GG (LGG) |
The intervention involves the daily supplementation of Lactobacillus rhamnosus GG (LGG), a widely studied probiotic strain, at a dosage of 1 × 10^10 CFU (colony-forming units) per day. The intervention will be provided to children aged 3–14 years diagnosed with Autism Spectrum Disorder (ASD) for a period of 12 weeks.
Key Details:
Formulation: LGG will be administered in a child-friendly format (e.g., sachets or capsules).
Control Group: A placebo identical in appearance, taste, and packaging will be administered to the control group to maintain blinding.
Storage and Handling: Both the LGG supplement and placebo will be stored under controlled conditions to maintain stability and potency, adhering to Good Manufacturing Practices (GMP).
Objective: To assess the impact of LGG on behavioral outcomes, quality of life, and gut microbiota composition in children with ASD. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 Children aged 3 to 14 years
2 Confirmed diagnosis of Autism Spectrum Disorder ASD based on DSM V criteria
3 Written informed consent provided by parents or legal guardians
4 Participants and their families are willing to comply with study procedures and intervention schedule |
|
| ExclusionCriteria |
| Details |
1 Children with renal pulmonary cardiac or hepatic dysfunction that could impact study outcomes
2 Presence of intellectual disability or global developmental delay unrelated to Autism Spectrum Disorder ASD
3 Weight for length or height for age less than 3 standard deviations below the mean based on WHO growth charts
4 Recent use of antibiotics within two months prior to enrollment
5 Use of probiotics or probiotic supplements within the past six months
6 History of inflammatory bowel disease celiac disease eosinophilic disorders eg eosinophilic esophagitis or prior bowel surgery
7 Current use of chronic anti inflammatory medications within two months before enrollment
8 Families unable to adhere to study procedures intervention schedules or follow up assessments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Overall Quality of Life (QoL):
Metric: Measured using the Quality-of-Life Autism (QoLA) questionnaire, designed to assess the well-being of children with Autism Spectrum Disorder (ASD) and their families.
|
Assessed at baseline (pre-intervention) and 12 weeks (post-intervention). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Behavioral Improvements:
Metric: Assessed using the Childhood Behavior Checklist (CBCL) and Autism Treatment Evaluation Checklist (ATEC) to evaluate reductions in anxiety, aggression, and irritability. |
Measured at baseline and 12 weeks post-intervention. |
Family Functioning:
Metric: Evaluated using the Brief Autism Mealtime Behavior Inventory (BAMBI) to assess improvements in family interactions during mealtimes. |
Assessed at baseline (pre-intervention) and 12 weeks (post-intervention). |
Gut Microbiome Modulation:
Metric: Changes in gut microbiota composition and diversity analyzed using 16S rRNA gene sequencing of stool samples. |
Assessed at baseline and 12 weeks post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [murchana12@gmail.com].
- For how long will this data be available start date provided 01-07-2028 and end date provided 20-07-2038?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIl
|
|
Brief Summary
|
Rationale:
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition often accompanied by behavioral challenges and gastrointestinal (GI) symptoms. Emerging evidence highlights a strong connection between the gut-brain axis, with disruptions in gut microbiota composition contributing to neurobehavioral symptoms in children with ASD. Lactobacillus rhamnosus GG (LGG), a well-studied probiotic, has demonstrated potential in enhancing gut integrity, reducing inflammation, and modulating the gut-brain axis. This study aims to address the gap in evidence on the impact of LGG supplementation on behavioral outcomes, quality of life, and gut microbiota in children with ASD.
Objective:
The primary objective is to evaluate the effects of LGG supplementation on the overall quality of life (QoL) of children with ASD and their families. Secondary objectives include assessing improvements in behavioral symptoms, family functioning, and gut microbiota diversity.
Method:
This is a triple-blind, randomized, placebo-controlled trial involving 140 children aged 3–14 years diagnosed with ASD (DSM-V criteria). Participants will be randomly assigned to receive either LGG (1 × 10^10 CFU/day) or a placebo for 12 weeks. Data will be collected at baseline and post-intervention using validated tools such as the Quality-of-Life Autism Questionnaire (QoLA), Childhood Behavior Checklist (CBCL), and 16S rRNA sequencing for gut microbiota analysis. Behavioral and QoL changes will be statistically evaluated, correlating findings with microbiota diversity and family dynamics. This study is expected to provide novel insights into the dual action of LGG in managing both GI and neurobehavioral symptoms in ASD populations, paving the way for non-invasive therapeutic approaches. |