Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

NCT05586139

Acute Malnutrition With no Complications

NOT_YET_RECRUITING NA

Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

NCT03533712

Small for Gestational Age at Delivery Low Birth Weight Prematurity +1 more

COMPLETED PHASE4

Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

NCT04103294

Dietary Exposure

COMPLETED NA

Introduction of MMS to Antenatal Care in Bamako, Mali

NCT05312242

Adherence, Medication

COMPLETED NA

Adolescent Nutrition in Girls in Burkina Faso and Ethiopia

NCT06444555

Nutrition Deficiency Due to Insufficient Food

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Microbiome, Human

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fermented porridge

this study arm participant will consume fermented millet porridge, daily

Group Type EXPERIMENTAL

Fermented porridge

Intervention Type OTHER

A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.

Non-fermented porridge

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

Group Type ACTIVE_COMPARATOR

Fermented porridge

Intervention Type OTHER

A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes