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Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 27, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
The purpose of this study is to determine the health impacts of consistent consumption of insect-fortified crackers among school-aged children in Madagascar. Specifically, in this RCT, the investigators will assess whether the insect-fortified crackers can improve the health status of Malagasy school children. The investigators' objectives are to: (1) Assess changes in gut microbiome composition that occur after 6 and 14 weeks of cracker consumption through 16S rRNA sequencing. (2) Assess changes in intestinal and systemic inflammation after 6 and 14 weeks of cracker consumption through quantification of fecal calprotectin, lactoferrin, myeloperoxidase (MPO), and alpha-1-antitrypsin (AAT) and circulating pro-inflammatory cytokines. (3) Assess changes in iron status after 14 weeks of cracker consumption through quantification of hemoglobin (Hb), inflammation-adjusted serum ferritin, and soluble transferrin receptor (sTfR).
Trial Details
NCT Number NCT07439185
Lead Sponsor Cornell University
Collaborators: PATH, Institut Pasteur de Madagascar, Université d'Antananarivo
Conditions
(from sponsor)		 Gut -Microbiota, Inflamation, Iron Absorption
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov