Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women (LAFIABAGA)

Institut de Recherche en Sciences de la Sante, Burkina Faso

Status: Enrolling

Conditions: Microbiome, Human; Inflammation

Treatments: Other: Fermented porridge

Study type: Interventional

Funder types: Other

Identifiers

NCT05299970

NUT_IRSS_0001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

fermented porridge

Experimental group

Description:

this study arm participant will consume fermented millet porridge, daily

Treatment:

Other: Fermented porridge

Non-fermented porridge

Active Comparator group

Description:

this study arm participants will consume non-fermented millet porridge, daily

Treatment:

Other: Fermented porridge