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CTRI Number  CTRI/2025/09/094106 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative Longitudinal Study 
Study Design  Other 
Public Title of Study   Understanding Causes and Outcomes of Acute Diarrhea in Severely Malnourished Children 
Scientific Title of Study   Clinicoetiological spectrum and outcomes of children with acute diarrhea and severe acute malnutrition 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manik Kotra 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Ward 19A Department of Pediatrics Maulana Azad Medical College ,2,Bahadurshah Zafar Marg , New Delhi-02

Central
DELHI
110002
India 
Phone  8082746958  
Fax    
Email  manikkotra11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghvendra Singh  
Designation  Professor 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Ward 19A Department of Pediatrics Maulana Azad Medical College ,2,Bahadurshah Zafar Marg , New Delhi-02

Central
DELHI
110002
India 
Phone  9968604426  
Fax    
Email  drraghvendrasingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raghvendra Singh 
Designation  Professor 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Ward 19A Department of Pediatrics Maulana Azad Medical College ,2,Bahadurshah Zafar Marg , New Delhi-02

Central
DELHI
110002
India 
Phone  9968604426  
Fax    
Email  drraghvendrasingh@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College and Lok Nayak Hospital  
Address  Maulana Azad Medical College,2, Bahadurshah Zafar Marg , New Delhi-110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manik Kotra  Lok Nayak Hospital, New Delhi  Department of Pediatrics, Maulana Azad Medical College ,2, Bahadurshah Zafar Marg ,New Delhi ,110002
Central
DELHI 		 8082746958

manikkotra11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and Associated Hospitals (Lok Nayak ,GB Pant Institute Post Graduate Medical Education (GIPMER) and Research Hospital ,Guru Nanak Eye Centre) , New Delhi-110002   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Group 1 : Children aged 6 months to 5 years diagnosed with acute diarrhea (less than or equal to 14 days duration) with SAM ( as per WHO criteria).

Group 2: SAM children without diarrhea needing hospitalization .  
 
ExclusionCriteria 
Details  1.Chronic diarrhea .
2.Congenital or metabolic disorders affecting growth or gut function.
3.Re-admissions or referred cases after treatment elsewhere.
4.Coexisting chronic systemic illness (e.g. chronic heart, kidney, hematological, liver, or gastrointestinal disease), known primary/acquired immunodeficiency or immunosuppression.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome variable: Difference in mean duration of hospital stay between children with acute diarrhea and severe acute malnutrition and those with SAM and Hospitalization.  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Median duration in clinical rehydration (in hours) and stool recovery (Bristol 5 or less) between the two groups.
2.Proportion of bacterial and parasitic pathogen in stool sample from Group 1.
3.Frequency and pattern of clinical symptoms (e.g., fever, vomiting, dehydration, lethargy) and complications (e.g., electrolyte imbalance, hypoglycemia, shock, sepsis) between Group 1 and Group 2.
4.Proportion of co-morbid illnesses such as pneumonia, sepsis, anemia, or tuberculosis, in Group 1 and Group 2, and their association with hospital stay and adverse outcomes.
5.Relationship between median duration of hospital stay with anthropometric indicators.
6.Proportion of children requiring intensive care support (ICU admission or advanced life support) and mortality between Group 1 and Group 2.
 		 1 week 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   20/09/2025 
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="1"
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included manikkotra11@gmail.com).

  6. For how long will this data be available start date provided 20-12-2029 and end date provided 20-12-2034?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Stool samples (approx. 5g) will be collected in sterile containers and transported to the Enterobacteriaceae laboratory within two hours. If delayed beyond two hours, the sample will be partially inoculated in enrichment media (selenite F broth and alkaline peptone water) and stored at 4–8°C, to be delivered within 12 hours.

The stool samples will undergo:

  1. Macroscopic examination – for color, consistency, blood, mucus, or worms.

  2. Microscopic examination – using saline and iodine wet mounts to detect protozoa, helminths, and other components.

  3. Culture – on selective media after direct and enrichment inoculation; organisms will be identified via colony morphology, biochemical tests, and MALDI-TOF.

  4. Serotyping – confirmed with slide agglutination using specific antisera for Salmonella and Shigella.

  5. Antimicrobial susceptibility testing – performed using disk diffusion and broth microdilution methods as per CLSI guidelines.

The study will be carried out at Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, under standard protocols from the Ministry of Health and Family Welfare, India.

 
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