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 1/2

Not yet recruiting

• Conditions: Unspecified protein-calorie malnutrition,

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

Brief Summary

Brief Summary: Undernutritionis not simply caused by lack of nutritious food but also the ability toefficiently assimilate nutrients from diet where the gut microbiota plays acritical role enabling the host to maintain energy balance and overall health.Dysbiosis in the gut microbiota composition are now being causally linked toundernutrition, although current modalities of treatment do not encompass waysto address these challenges.

Our study employs a modern take on nutritional interventions for themanagement of severe and moderate acute malnutrition by combining a nutritionaland a microbiota targeted intervention not only to deliver sufficient caloriesbut also to improve the gut microbiota composition for sustained healthbenefits even after cessation of the nutritional therapy.

We intend to use a finger millet based dietary supplement which is richin dietary fibers to improve gut microbiome composition and in turn overallenergy balance in under 5 years old children with severe and moderate acutemalnutrition, in comparison to a high-energy wheat based supplement with a muchlower dietary fiber content.

We will conduct randomised control trials to test the effect of a fingermillet based dietary intervention on the gut microbiome and its impact on thenutritional status measured by anthropometry of undernourished children fromAnganwadi schools in three different states.

Both soluble and insoluble/non-digestible dietary fibers have a profoundeffect on the gut microbiota. Finger millets are a rich source of high-qualitybeneficial dietary fibers as well as polyphenols with anti-inflammatoryproperties. Use of finger millets should provide an avenue to correctunderlying pathologies of undernutrition and help in establishing a moreresilient process of energy assimilation through the harmonious action ofmicrobial and host components in the gut.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1800

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 health	Baseline(0 day) | Endpoint (60 days)

Secondary Outcome Measures

Name	Time	Method
Improvement in weight gain	60th day to 120th day

Trial Locations

Locations (3)

Government Medical College, Thiruvananthapuram (GMCT); 🇮🇳 Thiruvananthapuram, KERALA, India

ICMR-National Institute of Nutrition; 🇮🇳 Hyderabad, TELANGANA, India

Society for Health and Demographic Surveillance (SHDS); 🇮🇳 Birbhum, WEST BENGAL, India

Government Medical College, Thiruvananthapuram (GMCT)

🇮🇳Thiruvananthapuram, KERALA, India

DrRaja Sriswan M

Principal investigator

9885594388

srishwan@gmail.com