Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi. (NCT03385590) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
Malawi158 participantsStarted 2018-06-21
Plain-language summary
The purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity.
Who can participate
Age range
6 Months – 36 Months
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:
* Willing to have height and weight measured and provide demographic information (e.g age, race, sex).
* Willing to consume soy fiber or control porridge twice daily for a 6 months' period
* Willing to complete a weekly questionnaire throughout the entire 6 months' study.
* Willing to be interviewed for 24-Hour recall 3 times per 6 months' period throughout the study.
* Willing to provide 3 stool samples, one in each 2-weeks period throughout the study.
Exclusion Criteria:
* Have any known food allergies.
* Are currently taking medications for diarrhea.
* Have taken antibiotics within the past four weeks prior to randomization.
* Have more than 3 diarrheal episodes in the last week
* Currently participating in a clinical trial.
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.