A clinical trial to study the effects of finger millet porridge to improve body weight and gut microbiota composition among uncomplicated malnourished children of under five years.

Understanding the effect of finger millet based dietary supplementation on anthropometry and gut microbial derangements in uncomplicated severe and moderate acute malnutrition in under 5 children- a multi-centric study - NIl

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021348

Enrollment

1800

Registered

2019-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E46- Unspecified protein-calorie malnutrition

Interventions

Intervention1: Finger Millet Porridge: 75 grams of the finger millet based intervention will be provided once daily for a period of two months by mixing it with hot water to form a porridge Nutrition

Eligibility

Inclusion criteria

Inclusion criteria: 1.For Severe acute malnutrition (SAM) children, weight-for-height z-score (WHZ) should be less than -3 below the median of the WHO child growth standards 2.For Moderate acute malnutrition (MAM) children, weight-for-height z-score (WHZ) should be between -2 and -3 below the median of the WHO child growth standards 3.For Apparently Healthy (AH) children, weight-for-height z-score (WHZ) should be between -1 and +1 of the median of the WHO child growth standards

Exclusion criteria

Exclusion criteria: 1.Birth weight less than 2.5 kgs 2.Diagnosed to have any chromosomal syndromes or anomalies 3.History of diarrhea, severe acute respiratory illness (SARI) or any other serious ailment requiring hospital admission within a period of at least four weeks before fecal sample collection 4.Consumed any antibiotics, antacids, probiotics, prebiotics, medications containing alcohol or any other products capable of drastically altering the gut microbiome, within a period of at least four weeks before fecal sample collection 5.Requires use of medication or undergoes any medical procedure for treatment of any infection/condition during the feeding trial or follow up period of up to 6months, that may alter the microbiome profile of the gut

Design outcomes

Primary

Measure	Time frame
Improved body weight and improved gut microbiota healthTimepoint: Baseline(0 day) Endpoint (60 days)	—

Secondary

Measure	Time frame
Improvement in weight gainTimepoint: 60th day to 120th day	—

Countries

India

Contacts

Public ContactDEVARAJ J PARASANNANAVAR

International Crops Research Institute for the Semi-Arid Tropics

r.k.varshney@cgiar.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026