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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indian Council of Medical Research ICMR
- Enrollment
- 900
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 8.00 Month(s) to 15.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Investigators
Dr Devaraj Parasannanavar
ICMR National Institute of Nutrition