Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron… (NCT07439185) | Clinical Trial Compass
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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
Madagascar650 participantsStarted 2026-02
Plain-language summary
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).
Who can participate
Age range
9 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for children
* Child (male, female, intersex, non-binary), aged 9 to 13 years old who attends one of the selected schools
* Caregiver or legal guardian is willing to provide informed consent
* Child is willing to provide informed assent
Exclusion criteria for children
* Child age is outside the preferred age range (9 to 13 years)
* Not enrolled in the participating schools
* Unable or unwilling to comply with the study requirements
* Illness requiring medical treatment, malaria, severe anemia (hemoglobin (Hb) concentration below 8.0 g/dL as indicated by HemoCue 201+ system), severe acute malnutrition, fever, diarrhea, etc.
* Covid-exposure or symptoms: loss of smell or taste
* History of food allergies or adverse reactions to any edible insects
* Chronic severe medical condition or congenital anomalies requiring frequent medical attention or interfering with dietary consumption
* Caregiver does not give consent, or child does not assent
Inclusion criteria for parents • Willing to participate in completing surveys about demographics and household dynamics (assets, housing structure, etc.)
Exclusion criteria for parents
• Caregiver does not consent to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut mircrobiome
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.
2
Iron via soluble transferrin receptor
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.
3
Intestinal inflammation via calprotectin
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.
4
Intestinal inflammation via lactoferrin
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.
5
Intestinal inflammation via lipocalin
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.
6
Intestinal inflammation via anlpha-1 antitrypsin
Timeframe: From enrollment to the end of treatment after 14 weeks of cracker consumption.