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CTRI Number  CTRI/2019/07/020029 [Registered on: 04/07/2019] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Understanding the effect of feeding practices of babies on their health status in rural areas through various approaches 
Scientific Title of Study   Impact of feeding practices and nutrition composition on infant health status of rural population- A multi-dimensional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidya Rajesh 
Designation  Dietician 
Affiliation  Manipal Academy of Higher Education 
Address  Room No. 4 Medicine OPD, DR. TMA PAI ROTARY HOSPITAL, Kabettu, Karkala.

Udupi
KARNATAKA
574104
India 
Phone  09482275837  
Fax    
Email  vidya.poojary@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asha Hegde 
Designation  Professor and HOD 
Affiliation  Manipal Academy of Higher Education 
Address  Room no 19, Department of Pediatrics, DR. TMA PAI ROTARY HOSPITAL. Kabettu, Karkala.

Udupi
KARNATAKA
574104
India 
Phone  09448824967  
Fax    
Email  asha.hegde@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Vidya Rajesh 
Designation  Dietician 
Affiliation  Manipal Academy of Higher Education 
Address  Room No 4, Medicine 0PD, Dr. TMA Pai Rotary Hospital, Kabettu,Karkala.

Udupi
KARNATAKA
574104
India 
Phone  09482275837  
Fax    
Email  vidya.poojary@manipal.edu  
 
Source of Monetary or Material Support  
Vidya Rajesh, Dr. TMA Pai Rotary Hospital, Karkala, Udupi, Karnataka. 
 
Primary Sponsor  
Name  Vidya Rajesh 
Address  Dr TMA Pai Rotary Hospital Karkala,Udupi, Karnataka. 
Type of Sponsor  Other [Self] 
 
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 
Vidya Rajesh  Dr TMA Pai Rotary Hospital  Room No 19 Pediatrics OPD Department of Pediatrics
Udupi
KARNATAKA 
9482275837

vidya.poojary@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy full term new borns 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Healthy full-term babies born in TMA Pai Rotary Hospital, Karkala.
cohort- Mother and baby pair residing within 30kms of Karkala 
 
ExclusionCriteria 
Details  Babies born before 37 weeks of gestation or having congenital abnormalities.
Mothers not willing to participate in the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To be able to evaluate the effect of type of infant feeding and nutrient composition of the diet on the development of gut microbiome.  4th year 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze the effect of infant nutrition-gut microbiome association on body composition, the frequency of infectious diseases and development milestones in infants.  4th year 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   08/07/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Adequate nourishment is important for physical growth and mental development during infancy. It is also a phase of maximum brain development wherein insufficient food intake would lead to irreversible damage (Rai, 2011). Assessing the nutritional status of rural infants is pivotal, as about 67% of Indian population still live in rural areas (data world bank, 2018). In India, research prioritization in Maternal, Newborn, Child Health and Nutrition (MNCHN) themes have traditionally involved only a handful of experts mainly hailing from major cities (Narendra K. Arora, 2017). This gives the opportunity to review infant nutritional status in a rural population.
Development of the gut microbiota during infancy functions as an important determinant of future health status (Yang, 2016). Dietary habits regulate what we are “feeding” our microbiota (Kashtanova, 2016), as the nutrient provided acts as a substrate for microbial metabolism. Diet composition and feeding practices during the first years of life may impact the diversity and functional capacity of the gut microbiome with potential downstream effects on infant development and disease risk (Johnson & Versalovic, 2012). Gut microbiome is now believed to affect the body mass index (BMI), as well as cognitive and neurological developments. Studying the growth trajectory and developmental milestones will provide a clear picture of the inter-relationship among nutrition, gut microbiome, BMI and development in an infant.
Malnutrition is also linked with impaired immunity with consequently increased risk to infections and cytokine activation (Uday A. Paia, 2018). Studying the frequency of acute respiratory infections (ARI) and acute diarrheal diseases (ADD), which are the most common illnesses in infancy, will aid in co-relating the impact of nutrition and composition of gut microbiome on the health profile of infants.
The study aims to evaluate the impact of infant nutrition in terms of feeding practices and nutrition composition on infant health with reference to multidimensional aspects including growth trajectory, development milestones, gut microbiome and disease pattern.
 
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