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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Microbiome, Human
• Intervention / Treatment: Other: Fermented porridge

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laeticia C TOE, MD; Phone Number: 0022671007272; Email: cellaety@yahoo.fr
• Study Contact Backup: Name: Lionel O Ouedraogo; Phone Number: 0022670530583; Email: lionel.olivier.ouedraogo@gmail.com

Study Locations

• Burkina Faso
  • Houet, Région Des hauts-Bassins
    • Bobo-Dioulasso, Houet, Région Des hauts-Bassins, Burkina Faso, 01 BP 545
      • Recruiting
      • IRSS-DRO
      • Contact: Lionel WB Ouedraogo, MD; Phone Number: +22670530583; Email: lionel.olivier.ouedraogo@gmail.com
      • Contact: Laeticia C TOE, MD; Phone Number: +22671007272; Email: cellaety@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fermented porridge; this study arm participant will consume fermented millet porridge, daily	Other: Fermented porridge; A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.
Active Comparator: Non-fermented porridge; this study arm participants will consume non-fermented millet porridge, daily	Other: Fermented porridge; A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota diversity	gut microbiota alpha and beta diversity	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	0 to 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of short chain fatty acid in stool	Concentration of C2-C8 fatty acids in stool	0 to 13 weeks
concentration of macronutrients in millet dough and porridge	Levels of carbohydrates, lipids, protein, dietary fiber and phytates	2 to 8 weeks
relative abundance of bacterial and fugal micro-organisms in millet dough and porridge	Count of microbial populations	2 to 8 weeks
Concentration of Ferritin in plasma	Ferritin levels in Plasma	0- to 13 weeks
Number of participant with anemia	hemoglobin concentration in grams per deciliter	0 to 13 weeks

Collaborators and Investigators

• Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Collaborators: Bill and Melinda Gates Foundation; University Ghent
• Investigators: Principal Investigator: Laeticia C TOE, IRSS-DRO

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: NUT_IRSS_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing plans will be done according to the BMGF policy
• IPD Sharing Supporting Information Type: ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No