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.

Phase 1

• Conditions: Health Condition 1: E46- Unspecified protein-calorie malnutrition

• Registration Number: CTRI/2019/09/021348
• Lead Sponsor: The International Crops Research Institute for the SemiArid Tropics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved body weight and improved gut microbiota healthTimepoint: Baseline(0 day) <br/ ><br>Endpoint (60 days)

Secondary Outcome Measures

Name	Time	Method
Improvement in weight gainTimepoint: 60th day to 120th day