The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Mate… (NCT07718087) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Maternal Nutritional Intake, Breastfeeding Practices, Infant Growth, and Gut Microbiota: A Randomized Controlled Trial
Indonesia50 participantsStarted 2026-08-01
Plain-language summary
This randomized controlled trial aims to evaluate the effects of structured lactation nutrition education combined with Dali ni Horbo supplementation on maternal dietary intake, breastfeeding practices, infant growth, and infant gut microbiota. Lactating mothers with healthy infants aged 0-1 month will be recruited from selected primary healthcare centers in Medan, Indonesia, and assigned to an intervention or control group. The intervention group will receive structured nutrition education and daily Dali ni Horbo, a traditional Batak fermented buffalo milk product, while the control group will receive standard care. Maternal energy and nutrient intake, nutritional knowledge and attitudes, exclusive breastfeeding practices, maternal and infant anthropometric measurements, intervention adherence, adverse effects, and infant fecal microbiota composition will be assessed before and after the intervention. This study is expected to determine whether integrating nutrition education with a nutrient-dense local food can improve maternal nutritional adequacy, support exclusive breastfeeding, promote optimal infant growth, and beneficially influence early-life gut microbiota.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
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:
* Lactating mothers aged 18-40 years.
* Having a healthy, singleton infant aged 0-1 month at enrollment.
* Residing within the service areas of the participating primary healthcare centers in Medan, Indonesia.
* Currently breastfeeding and intending to continue breastfeeding throughout the study period.
* Able to consume Dali ni Horbo and willing to follow the assigned intervention.
* Willing to participate in all study assessments, including dietary assessment, anthropometric measurements, and infant stool collection.
* Able to communicate effectively and complete the study questionnaires.
* Willing to provide written informed consent.
Exclusion Criteria:
* Mothers or infants with medical conditions that may significantly affect breastfeeding, maternal nutritional status, nutrient metabolism, or infant growth.
* Mothers with severe postpartum complications or conditions requiring hospitalization.
* Infants with congenital abnormalities, gastrointestinal disorders, metabolic diseases, severe infections, or other conditions affecting feeding or growth.
* Infants born preterm or with low birth weight, according to the study protocol.
* Mothers with a known allergy or intolerance to buffalo milk, cow's milk, or dairy products.
* Mothers following a medically prescribed restrictive diet that could affect the study outcomes.
* Current participation in another nutritional or clinical intervention study.
* Use of nutritional supplements, probiotics, antibiotic…
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.