Gut -MicrobiotaNCT07439185
Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren
A study testing Cricket and Black Soldier Fly Larvae-fortified Cracker and Rice and Corn Cracker in people with Gut -Microbiota and Inflamation, run by Cornell University at 1 site in Madagascar.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut -Microbiota, Inflamation, Iron Absorption
- What is being tested?
- Cricket and Black Soldier Fly Larvae-fortified Cracker and Rice and Corn Cracker
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteMadagascar
- Study dates
- Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.)
- Caregiver does not consent to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madagascar1 site
FSRP Sschools
Antsirabe, Vakinankaratra Region
John Hoddinott, PhD, 240-447-0918, jfh246@cornell.edu
Megan Parker, PhD, 202-460-6239, mparker@path.org
About this study
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).
Read the detailed description
Food insecurity, child malnutrition, and anemia remain significant public health problems globally, including in Madagascar where 40% of children under 5 years of age are chronically malnourished (stunted), 8% are wasted, and 46% are anemic (DHS, 2021). Interventions aimed at addressing this have often foundered on the fact that the foods that would address these nutrient deficiencies are physically unavailable, too expensive for poor households to purchase, or contribute to climate change or environmental degradation. Consequently, there is interest in the development of novel food products that could contribute to reducing malnutrition in all its forms, without the drawbacks of relying on existing food products. One possibility is to develop food products based on insects. Edible insects are low-cost, climate friendly, with nutritional profiles akin to meat. They contain high amounts of protein, iron, and zinc while also providing a novel source of prebiotic fiber. It is hypothesized that insect-based foods could improve children's health outcomes as measured by gut inflammation, anemia, and growth. The investigators and others have developed an insect-fortified cracker snack, suitable for the nutritional requirements of school-age children living in Southeast Madagascar. The investigators have already assessed the product's nutrient profile. They also have documented the safety tests done to date; these show that the snack is safe for human consumption. The test results have been submitted to the Malagasy regulatory authority for registering food and health products and the government has approved the insect powders as food for human consumption and issued "Certificates for Human Consumption". The investigators have also conducted an acceptability trial that showed that child participants like the organoleptic characteristics of the crackers and regularly consume the crackers in biologically meaningful quantities.
- Conditions
- Gut -Microbiota, Inflamation, Iron Absorption
- Being tested
- Cricket and Black Soldier Fly Larvae-fortified Cracker, Rice and Corn Cracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricket and Black Soldier Fly Larvae-fortified CrackerDietary supplement
Also called Treatment Cracker
Children will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks.
Rice and Corn CrackerDietary supplement
Also called Control Cracker
Children will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Consumption of insect-fortified (crickets and black soldier fly larvae) crackers. Receives: Dietary Supplement: Cricket and Black Soldier Fly Larvae-fortified Cracker |
| Control | Placebo comparator | Consumption of rice and corn crackers Receives: Dietary Supplement: Rice and Corn Cracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut mircrobiome
The investigators will assess gut microbiome composition at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through 16S rRNA sequencing and quantification of fecal biomarkers.
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via soluble transferrin receptor
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through soluble transferrin receptor (mg/L).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via calprotectin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: calprotectin (µg/g).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via lactoferrin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lactoferrin (µg/g).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via lipocalin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lipocalin (ng/g).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via anlpha-1 antitrypsin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: anlpha-1 antitrypsin (mg/g).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via myeloperoxidase
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: myeloperoxidase (µg/g).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Systemic inflammation via quantification of circulating cytokines
The investigators will also assess systemic inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through quantification of circulating cytokines, including IL-1β, IL-2, IL-4, IL-6, IL-10, IL-22, TNF-α, IFN-γ, CCL2, all expressed as pg/mL.
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via quantification of hemoglobin
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through quantification of hemoglobin (g/dL).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via inflammation adjusted ferritin
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through inflammation adjusted ferritin (µg/L).
Measured: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut -MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- PATH, Institut Pasteur de Madagascar, Université d'Antananarivo
- Responsible party
- Sponsor
- Investigators
- John Hoddinott, DPhil, Study chair, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439185
- Sponsor's protocol ID
- IRB0149913
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren
- ClinicalTrials.gov ID
- NCT07439185
- Acronym / sponsor ID
- IRB0149913
- Conditions
- Gut -Microbiota, Inflamation, Iron Absorption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- PATH, Institut Pasteur de Madagascar, Université d'Antananarivo
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Food insecurity, child malnutrition, and anemia remain significant public health problems globally, including in Madagascar where 40% of children under 5 years of age are chronically malnourished (stunted), 8% are wasted, and 46% are anemic (DHS, 2021). Interventions aimed at addressing this have often foundered on the fact that the foods that would address these nutrient deficiencies are physically unavailable, too expensive for poor households to purchase, or contribute to climate change or environmental degradation. Consequently, there is interest in the development of novel food products that could contribute to reducing malnutrition in all its forms, without the drawbacks of relying on existing food products. One possibility is to develop food products based on insects. Edible insects are low-cost, climate friendly, with nutritional profiles akin to meat. They contain high amounts of protein, iron, and zinc while also providing a novel source of prebiotic fiber. It is hypothesized that insect-based foods could improve children's health outcomes as measured by gut inflammation, anemia, and growth. The investigators and others have developed an insect-fortified cracker snack, suitable for the nutritional requirements of school-age children living in Southeast Madagascar. The investigators have already assessed the product's nutrient profile. They also have documented the safety tests done to date; these show that the snack is safe for human consumption. The test results have been submitted to the Malagasy regulatory authority for registering food and health products and the government has approved the insect powders as food for human consumption and issued "Certificates for Human Consumption". The investigators have also conducted an acceptability trial that showed that child participants like the organoleptic characteristics of the crackers and regularly consume the crackers in biologically meaningful quantities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Cricket and Black Soldier Fly Larvae-fortified CrackerConsumption of insect-fortified (crickets and black soldier fly larvae) crackers. |
| Control | Placebo comparator | Dietary Supplement: Rice and Corn CrackerConsumption of rice and corn crackers |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cricket and Black Soldier Fly Larvae-fortified CrackerAlso: Treatment CrackerChildren will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks. | Dietary supplement | Treatment |
| Rice and Corn CrackerAlso: Control CrackerChildren will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks. | Dietary supplement | Control |
Primary outcome
Gut mircrobiome
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess gut microbiome composition at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through 16S rRNA sequencing and quantification of fecal biomarkers.
Iron via soluble transferrin receptor
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through soluble transferrin receptor (mg/L).
Intestinal inflammation via calprotectin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: calprotectin (µg/g).
Intestinal inflammation via lactoferrin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lactoferrin (µg/g).
Intestinal inflammation via lipocalin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lipocalin (ng/g).
Intestinal inflammation via anlpha-1 antitrypsin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: anlpha-1 antitrypsin (mg/g).
Intestinal inflammation via myeloperoxidase
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: myeloperoxidase (µg/g).
Systemic inflammation via quantification of circulating cytokines
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will also assess systemic inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through quantification of circulating cytokines, including IL-1β, IL-2, IL-4, IL-6, IL-10, IL-22, TNF-α, IFN-γ, CCL2, all expressed as pg/mL.
Iron via quantification of hemoglobin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through quantification of hemoglobin (g/dL).
Iron via inflammation adjusted ferritin
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through inflammation adjusted ferritin (µg/L).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Hoddinott, DPhil study chair
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricket and Black Soldier Fly Larvae-fortified Cracker and Rice and Corn Cracker in people with Gut -Microbiota and Inflamation, run by Cornell University at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Hoddinott, DPhil (240-447-0918, jfh246@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut mircrobiome (time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.