CompletedNot Applicable

Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

Burkina Faso153 participantsStarted 2016-03

Plain-language summary

The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.

Who can participate

Age range

24 Weeks – 26 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6-6.5 month old infants * Weight for height and height for age z-score above -2 * Permanent resident of the area and not intending to move for the next 6 months for more than a week * No chronic antibiotic treatment * Exempt of any current serious illness * Still breastfed. Exclusion Criteria: * Moderate or severe malnutrition (weight for height or height for age z-score below -2) * non-permanent residence in the study area, * the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding * a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment * a history of allergy to a constituent of the supplement * a serious current illness

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fecal microbiota range-weighted richness

Timeframe: 6 months

Mean concentration of short-chain fatty acids in stool

Timeframe: 6 months

Trial details

NCT IDNCT02716935

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-24

View on ClinicalTrials.gov More Growth Retardation trials

Who can participate

Age range

24 Weeks – 26 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.