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Gut Inflammation Markers as Determinants of Response to Recovery in Uncomplicated Severely Malnourished Children

Gut Inflammation Markers as Determinants of Response to Treatment and Recovery in Children with Uncomplicated Severe Acute Malnutrition Undergoing Community Based Rehabilitation - Gut Markers predictor of recovery in SAM children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/02/006656
Enrollment
180
Registered
2016-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 2: null- Uncomplicated severe acute malnutrition

Interventions

Intervention1: Ready to Use Therapeutic Food-Centrally produced by an Indian company: Administration: Oral
Duration: 16 weeks or till recovery, Dose: As per weight Intervention2: Ready to Use Therapeutic Food-Locally produced by the study team: Administration: Oral
Duration: 16 weeks or till recovery, Dose: As per weight Control Intervention1: High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them. : Administr
Duration: 16 weeks or till recovery, Dose: As per weight

Sponsors

Society for Applied Studies
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Gut inflammation at enrolment by presence of elevated specified biomarkers and gut microbiota. Persistence of gut inflammation during early treatment phase (at recovery or 8 weeks post enrolment, whichever is earlier). Association between gut inflammation biomarkers, gut microbiota at enrolment and recovery and gain in weight and length/ height. Association between anorexia during the treatment phase and recovery and gain in weight and length/ height. Timepoint: Enrollment Recovery or 8 Weeks Enrolment to 16 Weeks Enrolment to 16 Weeks—

Secondary

MeasureTime frame
Examine microbioata of infants who recover and those that do not recover at recovery or 8 weeks. Assess association between inflammation and microbiota.Timepoint: recovery or 8 weeks—

Countries

India

Contacts

Public ContactDr Sunita Taneja

Society for Applied Studies

sunita.taneja@sas.org.in46043751-55

Outcome results

None listed

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