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CTRI Number  CTRI/2026/02/104139 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of Millet- and Wheat-Based Microbiota-Directed Complementary Foods on Growth and Gut Health of Children Aged 9–24 Months: A Community-Based Study in India 
Scientific Title of Study   Effect Of microbiota-directed complementary foods in improving growth and gut health among healthy and malnourished Children: A dual community-based randomized trial in India 
Trial Acronym  MDCF- Infant’s Growth- GUT Health 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devaraj Parasannanavar 
Designation  Scientist E 
Affiliation  ICMR National Institute of Nutrition 
Address  Maternal and Child Health Nutrition Jamai Osmania PO Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  8074928620  
Fax    
Email  jpdevraj26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devaraj Parasannanavar 
Designation  Scientist E 
Affiliation  ICMR National Institute of Nutrition 
Address  Maternal and Child Health Nutrition Jamai Osmania PO Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  8074928620  
Fax    
Email  jpdevraj26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemant Mahajan 
Designation  Scientist E  
Affiliation  ICMR National Institute of Nutrition 
Address  Maternal and Child Health Nutrition Jamai-Osmania PO Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  9666954994  
Fax    
Email  hemant.mahajan.84@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  V Ramalingaswami Bhawan PO Box No 4911 Ansari Nagar New Delhi 110029 India  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemant Mahajan  Hyderabad   District of Hyderabad Rangareddy
Hyderabad
TELANGANA 		 09666954994

hemant.mahajan.84@gmail.com 
Dr Santosh Kumar B   Medchal - Malkajgiri  District of Medchal malkajgiri
Hyderabad
TELANGANA 		 988576760

drsantoshkumar999@gmail.com 
Dr D Teena   Uppal  District of Medchal malkajgiri
Hyderabad
TELANGANA 		 8897950177

teenarajeev@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL 1 (C1) AND CONTROL 2 (C2)  Comparator agent: Participants in the control arm of Trial 1 (healthy Children) will receive the standard THR provided under ICDS, known as Balamrutham Control 1 (C1) in Telangana. In Trial 2, the control group will receive the standard management for MAM i.e Balamrutham Plus Control 2 (C2): A fortified complementary food specifically designed for the nutritional rehabilitation of MAM children  
Intervention  MDCF-1, MDCF-2 , MDCF-3, MDCF-4  Trial1 : Name : MDCF 1: Finger millet based Intervention Details: Each enrolled healthy child will receive a finger millet–based intervention of 100 grams per day. The supplement will be provided for duration of 12 months, divided into two freshly prepared servings per day, reconstituted in hot water before feeding Name: MDCF 2: Wheat based Nutritional intervention Details: Each enrolled healthy child will receive a wheat based intervention of 100 grams per day. The supplement will be provided for duration of 12 months, divided into two freshly prepared servings per day, reconstituted in hot water before feeding Trail 2: Name: MDCF 3: Finger Millet based Nutritional intervention Details: Each enrolled MAM (Moderately Acute Malnourished) child will receive a finger millet–based intervention ranging from 90 to 180 grams per day, depending on the child’s body weight. The supplement will be provided for duration of six months and 6 months Follow-up period, divided into two freshly prepared servings per day, reconstituted in hot water before feeding Name : MDCF 4: Wheat based Nutritional intervention Details: Each enrolled MAM (Moderately Acute Malnourished) child will receive a finger millet–based intervention ranging from 90 to 180 grams per day, depending on the child’s body weight. The supplement will be provided for duration of six months, and another 6 momnths follow-up period, divided into two freshly prepared servings per day, reconstituted in hot water before feeding.  
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  15.00 Month(s)
Gender  Both 
Details  Trial 1 Cluster Randomized Controlled Trial
Children eligible for Trial 1 will be apparently healthy infants aged 9 to 15 months at the time of enrolment, residing within the catchment areas of the selected Anganwadi Centers. Eligible children must not be severely undernourished, defined by a weight for length z score greater than minus two and less than plus one at baseline. Apparent health status is defined as the absence of any acute or chronic medical illness at the time of enrolment. Minor, self limiting conditions such as mild cough, common cold, or mild diarrhoea will not be considered exclusion criteria, provided the child is clinically stable and follow up is feasible. These criteria aim to include children who are representative of the general Anganwadi Center population while ensuring safety and reliable follow up throughout the intervention period.

Trial 2 Individual Randomized Controlled Trial
For Trial 2, eligible participants will be children aged 9 to 15 months diagnosed with moderate acute malnutrition. Moderate acute malnutrition is defined as a weight for length z score between minus three and minus two or a mid upper arm circumference between one hundred fifteen millimetres and one hundred twenty five millimetres, confirmed through two independent measurements. Children must be free from acute medical complications requiring inpatient care and should have no prior history of severe acute malnutrition, nutritional edema, or diagnosed chronic illnesses. Children with known food allergies that may interfere with safe consumption of the study foods will be excluded. In addition, families must intend to remain in the study area for the twelve month study duration, and written informed consent must be obtained from the parent or legal guardian. 
 
ExclusionCriteria 
Details  Trial 1 – Cluster Randomized Controlled Trial
Children will be excluded from Trial 1 if they meet any of the following criteria. Children with acute malnutrition, defined as a weight for length z score less than minus two or the presence of bilateral pitting edema, will not be eligible for participation. Any child identified with severe acute malnutrition at baseline will be referred to the nearest local health facility for appropriate treatment to ensure ethical and clinical safety. Children with chronic illnesses or congenital disorders that may affect growth or nutrient absorption, such as congenital heart defects, cerebral palsy, or cystic fibrosis, will be excluded. Children with a known or reported allergy or intolerance to any ingredient used in the study foods, including peanut allergy, will also be excluded. In addition, children presenting with an existing acute febrile illness at the time of enrolment will not be eligible for inclusion.

Trial 2 – Individual Randomized Controlled Trial
Children will be excluded from Trial 2 if they meet any of the following conditions. Children diagnosed with severe acute malnutrition, defined as a weight for length z score less than minus three or the presence of bilateral pitting edema, will be excluded. Any child identified with severe acute malnutrition at baseline will be referred to the nearest local health facility for appropriate treatment to ensure ethical safety. Children with chronic medical conditions, including but not limited to untreated tuberculosis, congenital heart disease, severe developmental disorders, or any condition known to affect growth or nutrient absorption, will not be eligible. Children with known or reported food allergies to any ingredients used in the study foods, such as peanut or milk allergy, will also be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Trial 1
Change in Weight-for-Age Z-Score (WAZ) from Baseline (0day) to 12 Months of supplementation
Trial 2
Change in Weight-for-Length Z-Score (WLZ) from Baseline (0day) to 6 Months of supplementation
 		 Time points: 0 Day, 15 days , 30 days, 60 Days, 90 days, 120 days , 150 days , 180 days, 270 days, 360 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gut microbiota composition, microbial maturity, gut inflammation, immune biomarkers, and caregiver-reported adherence and acceptability  Time-points: Time points: 0 Day, 15 days , 30 days, 60 Days, 90 days, 120 days , 150 days , 180 days, 270 days, 360 days 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="900" 
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)   02/03/2026 
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="2"
Months="9"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - Proposals should be directed to [jpdevraj26@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 30-09-2030?
    Response - Immediately following publication. No end date.

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

This proposal aims to assess the effectiveness of both cereal based and millet based microbiota directed complementary foods in promoting growth and restoring gut health in children aged nine to eighteen months. Two parallel randomized controlled trials will be conducted. The first will be a three arm cluster randomized controlled trial among apparently healthy children aged twelve to eighteen months to evaluate preventive benefits. The second will be a three arm individually randomized open label randomized controlled trial among children with moderate acute malnutrition aged nine to eighteen months to evaluate therapeutic effects. The primary outcomes will include changes in weight for age z scores and weight for length z scores. Secondary outcomes will include gut microbiota composition, microbial maturity, gut inflammation, immune biomarkers, and caregiver reported adherence and acceptability.

The interventions will span a period of six to twelve months, with an additional six month follow up in the moderate acute malnutrition trial. Gut microbiota and biomarker assessments will be conducted using stool and blood samples, along with comprehensive dietary and anthropometric evaluations.

By comparing millet based and cereal based microbiota directed complementary foods against ready to use complementary foods or standard take home rations, this study will generate robust and context specific evidence to inform national complementary feeding strategies. The study is expected to provide new insights into the causal role of the gut microbiota in child growth and development, offering a transformative approach to managing under nutrition by integrating dietary therapy with microbiome restoration.

 
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