Clinical trial NCT05299970: Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammation
Microbiome, Human
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: University Ghent
name: Bill and Melinda Gates Foundation
First posted: 2022-03-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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-

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gut microbiota diversity
timeFrame: 0 to 13 weeks
measure: Concentration of inflammation markers in blood and stool
timeFrame: 0 to 13 weeks
Secondary outcomes:
measure: Concentration of short chain fatty acid in stool
timeFrame: 0 to 13 weeks
measure: concentration of macronutrients in millet dough and porridge
timeFrame: 2 to 8 weeks
measure: relative abundance of bacterial and fugal micro-organisms in millet dough and porridge
timeFrame: 2 to 8 weeks
measure: Concentration of Ferritin in plasma
timeFrame: 0- to 13 weeks
measure: Number of participant with anemia
timeFrame: 0 to 13 weeks
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: IRSS-DRO
state: Houet, Région Des hauts-Bassins
Study officials:
affiliation: IRSS-DRO
name: Laeticia C TOE
role: PRINCIPAL_INVESTIGATOR
References: