se of Finger Millet in moderate acute malnutrition in under 5 childre

Phase 3

• Conditions: Health Condition 1: E440- Moderate protein-calorie malnutrition

• Registration Number: CTRI/2023/06/053590
• Lead Sponsor: ICMR National Institute of Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Only children aged 30 to 59 months (below 5 years) will be enrolled in the study

2.Children detected for the first time (primary) with Moderate acute malnutrition (MAM) having weight-for-height z-score (WHZ) between -2 and -3 below the median of the WHO child growth standards. These are children who have never been previously diagnosed or received any treatment for undernutrition (based on anthropometry records maintained at Anganwadi centers).

3.For Control or Apparently Healthy (AH) children, weight-for-height z-score (WHZ) should be between -1 and +1 of the medians of the WHO child growth standards.

4.They also should never have been previously diagnosed or received any treatment for undernutrition

Exclusion Criteria

1 Any congenital/acquired disorder affecting growth i.e. known case of trisomy-21 or cerebral palsy

2.Children having Severe anemia ( <8mg/dl) as assessed by Hemocue (Model no. Hemocue Hb 301)

3.Children with dietary caloric insufficiency (as assessed through 24-hour dietary recall method) will be excluded from the study

4.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 will not be included in the study

5.Subjects who have consumed or will need to consume any antibiotics, probiotics, prebiotics, or any other products capable of drastically altering the gut microbiome, within a period of at least four weeks before enrolment in the study or anytime during the trial, will be excluded from the study

6.Receiving concurrent treatment for another condition

7.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 6 months, that may alter the microbiota profile of the gut, will be excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in gut microbiota structure and function <br/ ><br>Timepoint: 0 days <br/ ><br>30 days <br/ ><br>60 days <br/ ><br>120 days <br/ ><br>180 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Improved weight gainTimepoint: 0 days <br/ ><br>30 days <br/ ><br>60 days <br/ ><br>120 days <br/ ><br>180 days