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

Primary Purpose

Inflammation, Microbiome, Human

Status
Recruiting
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Fermented porridge
Sponsored by
Institut de Recherche en Sciences de la Sante, Burkina Faso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Inflammation

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts 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

Sites / Locations

  • IRSS-DRORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fermented porridge

Non-fermented porridge

Arm Description

this study arm participant will consume fermented millet porridge, daily

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

Outcomes

Primary Outcome Measures

Gut microbiota diversity
gut microbiota alpha and beta diversity
Concentration of inflammation markers in blood and stool
Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2022
Last Updated
October 18, 2023
Sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators
University Ghent, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05299970
Brief Title
Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators
University Ghent, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Microbiome, Human

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fermented porridge
Arm Type
Experimental
Arm Description
this study arm participant will consume fermented millet porridge, daily
Arm Title
Non-fermented porridge
Arm Type
Active Comparator
Arm Description
this study arm participants will consume non-fermented millet porridge, daily
Intervention Type
Other
Intervention Name(s)
Fermented porridge
Intervention Description
A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.
Primary Outcome Measure Information:
Title
Gut microbiota diversity
Description
gut microbiota alpha and beta diversity
Time Frame
0 to 13 weeks
Title
Concentration of inflammation markers in blood and stool
Description
Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin
Time Frame
0 to 13 weeks
Secondary Outcome Measure Information:
Title
Concentration of short chain fatty acid in stool
Description
Concentration of C2-C8 fatty acids in stool
Time Frame
0 to 13 weeks
Title
concentration of macronutrients in millet dough and porridge
Description
Levels of carbohydrates, lipids, protein, dietary fiber and phytates
Time Frame
2 to 8 weeks
Title
relative abundance of bacterial and fugal micro-organisms in millet dough and porridge
Description
Count of microbial populations
Time Frame
2 to 8 weeks
Title
Concentration of Ferritin in plasma
Description
Ferritin levels in Plasma
Time Frame
0- to 13 weeks
Title
Number of participant with anemia
Description
hemoglobin concentration in grams per deciliter
Time Frame
0 to 13 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laeticia C TOE, MD
Phone
0022671007272
Email
cellaety@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lionel O Ouedraogo
Phone
0022670530583
Email
lionel.olivier.ouedraogo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laeticia C TOE
Organizational Affiliation
IRSS-DRO
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRSS-DRO
City
Bobo-Dioulasso
State/Province
Houet, Région Des hauts-Bassins
ZIP/Postal Code
01 BP 545
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel WB Ouedraogo, MD
Phone
+22670530583
Email
lionel.olivier.ouedraogo@gmail.com
First Name & Middle Initial & Last Name & Degree
Laeticia C TOE, MD
Phone
+22671007272
Email
cellaety@yahoo.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing plans will be done according to the BMGF policy

Learn more about this trial

Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

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