Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

Inflammation Clinical Trial

— LAFIABAGA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299970
• Other study ID #: NUT_IRSS_0001
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Contact: Laeticia C TOE, MD
• Phone: 0022671007272
• Email: cellaety[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Microbiome, Human

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	IRSS-DRO	Bobo-Dioulasso	Houet, Région Des hauts-Bassins

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche en Sciences de la Sante, Burkina Faso	Bill and Melinda Gates Foundation, University Ghent

Country where clinical trial is conducted

Burkina Faso, 

Outcome

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