InflammationLAFIABAGANCT05299970
Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women
A study testing Fermented porridge in people with Inflammation and Microbiome, Human, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
Trial summary
Maternal undernutrition concerns 10-19% of women of reproductive age globally, the vast majority of which live in sub Saharan Africa and south Asia. Recommendations for nutritional interventions to tackle the problem range from per-pregnancy supplementation to upstream interventions targeting women of reproductive age… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Microbiome, Human
- What is being tested?
- Fermented porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 21 Mar 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant are
- 18 to 49 years old
- Resident in the study area and do not plan to move within 5 months following the start of the study
- Are not on antibiotic treatment on inclusion and have not been in the previous 3 weeks.
- Do not suffer from any pathology that could interfere with their diet.
- Have no known allergy to pearl millet or its derivatives
- Agree to sign a consent to participate in the study-
Who cannot join
- Women under 18 or over 49
- Women not consuming pearl millet porridge due to allergy or food preference
- Women planning to move from the study area within 5 months of the start of the study
- Women with serious illnesses that may interfere with their diet
- Women on antibiotic treatment or at the time of inclusion or having been in the previous 3 weeks.
- In addition, women who will benefit from antibiotic therapy during the study will be excluded from the analysis
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site, 1 recruiting
- Recruiting
IRSS-DRO
Bobo-Dioulasso, Houet, Région Des hauts-Bassins, 01 BP 545
Lionel WB Ouedraogo, MD, +22670530583, lionel.olivier.ouedraogo@gmail.com
Laeticia C TOE, MD, +22671007272, cellaety@yahoo.fr
About this study
Official title: Effect of Fermented Millet Porridge on Gut Microbiota Diversity and Inflammation Markers in Women of Reproductive Age in Rural Burkina Faso: A Pilot Study
Maternal undernutrition concerns 10-19% of women of reproductive age globally, the vast majority of which live in sub Saharan Africa and south Asia. Recommendations for nutritional interventions to tackle the problem range from per-pregnancy supplementation to upstream interventions targeting women of reproductive age before conception. To render the latter interventions cost-effective and sustainable, experts recommend to focus on food processing that leads to an enhanced nutrient content. One such method, which has been known and practiced for centuries in diverse societies, is fermentation. Traditionally fermented foods are diverse, widespread and highly appreciated in Burkina Faso. The present study aims to investigate the effect of fermented millet porridge on gut microbiota diversity, stool short chain fatty acid concentration and inflammation markers level in women of reproductive age living in rural Burkina Faso.
- Conditions
- Inflammation, Microbiome, Human
- Being tested
- Fermented porridge
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented porridgeOther
A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.
| Study group | Role | What they receive |
|---|---|---|
| fermented porridge | Experimental | this study arm participant will consume fermented millet porridge, daily Receives: Other: Fermented porridge |
| Non-fermented porridge | Active comparator | this study arm participants will consume non-fermented millet porridge, daily Receives: Other: Fermented porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota diversity
gut microbiota alpha and beta diversity
Measured: 0 to 13 weeks
Concentration of inflammation markers in blood and stool
Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin
Measured: 0 to 13 weeks
Secondary outcomes (5)
Concentration of short chain fatty acid in stool
Concentration of C2-C8 fatty acids in stool
Measured: 0 to 13 weeks
concentration of macronutrients in millet dough and porridge
Levels of carbohydrates, lipids, protein, dietary fiber and phytates
Measured: 2 to 8 weeks
relative abundance of bacterial and fugal micro-organisms in millet dough and porridge
Count of microbial populations
Measured: 2 to 8 weeks
Concentration of Ferritin in plasma
Ferritin levels in Plasma
Measured: 0- to 13 weeks
Number of participant with anemia
hemoglobin concentration in grams per deciliter
Measured: 0 to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start21 Mar 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- University Ghent, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Laeticia Celine Toe, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Investigators
- Laeticia C TOE, Principal investigator, IRSS-DRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299970
- Sponsor's protocol ID
- NUT_IRSS_0001
- Acronym
- LAFIABAGA
- Status last verified
- Oct 2023
- First submitted
- 20 Mar 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plans will be done according to the BMGF policy
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fermented Millet Porridge on Gut Microbiota Diversity and Inflammation Markers in Women of Reproductive Age in Rural Burkina Faso: A Pilot Study
- ClinicalTrials.gov ID
- NCT05299970
- Acronym / sponsor ID
- LAFIABAGA / NUT_IRSS_0001
- Conditions
- Inflammation, Microbiome, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina FasoOther government
- Collaborators
- University Ghent, Bill and Melinda Gates Foundation
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 29 Mar 2022 (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.
Maternal undernutrition concerns 10-19% of women of reproductive age globally, the vast majority of which live in sub Saharan Africa and south Asia. Recommendations for nutritional interventions to tackle the problem range from per-pregnancy supplementation to upstream interventions targeting women of reproductive age before conception. To render the latter interventions cost-effective and sustainable, experts recommend to focus on food processing that leads to an enhanced nutrient content. One such method, which has been known and practiced for centuries in diverse societies, is fermentation. Traditionally fermented foods are diverse, widespread and highly appreciated in Burkina Faso. The present study aims to investigate the effect of fermented millet porridge on gut microbiota diversity, stool short chain fatty acid concentration and inflammation markers level in women of reproductive age living in rural Burkina Faso.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fermented porridge | Experimental | Other: Fermented porridgethis study arm participant will consume fermented millet porridge, daily |
| Non-fermented porridge | Active comparator | Other: Fermented porridgethis study arm participants will consume non-fermented millet porridge, daily |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant are
- 18 to 49 years old
- Resident in the study area and do not plan to move within 5 months following the start of the study
- Are not on antibiotic treatment on inclusion and have not been in the previous 3 weeks.
- Do not suffer from any pathology that could interfere with their diet.
Key exclusion criteria (6 listed)
- Women under 18 or over 49
- Women not consuming pearl millet porridge due to allergy or food preference
- Women planning to move from the study area within 5 months of the start of the study
- Women with serious illnesses that may interfere with their diet
- Women on antibiotic treatment or at the time of inclusion or having been in the previous 3 weeks.
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 |
|---|---|---|
| Fermented porridgeA millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed. | Other | Non-fermented porridge, fermented porridge |
Primary outcome
Gut microbiota diversity
Time frame: 0 to 13 weeks
gut microbiota alpha and beta diversity
Concentration of inflammation markers in blood and stool
Time frame: 0 to 13 weeks
Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin
5 secondary outcomes
Concentration of short chain fatty acid in stool
Time frame: 0 to 13 weeks
concentration of macronutrients in millet dough and porridge
Time frame: 2 to 8 weeks
relative abundance of bacterial and fugal micro-organisms in millet dough and porridge
Time frame: 2 to 8 weeks
Concentration of Ferritin in plasma
Time frame: 0- to 13 weeks
Number of participant with anemia
Time frame: 0 to 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. Data sharing plans will be done according to the BMGF policy
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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. This study is not recruiting at the moment.
Laeticia C TOE principal investigator
IRSS-DRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented porridge in people with Inflammation and Microbiome, Human, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Burkina Faso. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laeticia C TOE, MD (0022671007272, cellaety@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota diversity (time frame: 0 to 13 weeks). The study lists 2 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 23 Oct 2023.