Gut Inflammation Markers as Determinants of Response to Recovery in Uncomplicated Severely Malnourished Childre
Not Applicable
Completed
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseasesHealth Condition 2: null- Uncomplicated severe acute malnutrition
- Registration Number
- CTRI/2016/02/006656
- Lead Sponsor
- Society for Applied Studies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Age 6 to 59 months
- SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet, or both.
Exclusion Criteria
- Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
- Known allergy to animal milk or peanuts
- Likely to leave the study area permanently in the next 16 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gut inflammation at enrolment by presence of elevated specified biomarkers and gut microbiota. <br/ ><br> <br/ ><br>Persistence of gut inflammation during early treatment phase (at recovery or 8 weeks post enrolment, whichever is earlier). <br/ ><br> <br/ ><br>Association between gut inflammation biomarkers, gut microbiota at enrolment and recovery and gain in weight and length/ height. <br/ ><br> <br/ ><br>Association between anorexia during the treatment phase and recovery and gain in weight and length/ height. <br/ ><br>Timepoint: Enrollment <br/ ><br> <br/ ><br> <br/ ><br>Recovery or 8 Weeks <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Enrolment to 16 Weeks <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Enrolment to 16 Weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Examine microbioata of infants who recover and those that do not recover at recovery or 8 weeks. <br/ ><br> <br/ ><br>Assess association between inflammation and microbiota.Timepoint: recovery or 8 weeks