NCT06977113 Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome

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This trial targets 56 participants in total. It began in 2025-03-11 with a primary completion date of 2026-12.

Brief Summary

Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development. Breast milk contains sugars called oligosaccharides, which support the development of a healthy gut in babies. The foods that breastfeeding mothers eat might influence the sugars in their breast milk and the natural, friendly bacteria inside their babies' gut-called the gut microbiota-which are important for overall health. Fibre-rich foods like fruits, vegetables, whole grains, beans, and nuts, as well as fermented foods like yogurt and milk kefir, support a healthy gut. The main aim of this study is to find out whether eating foods rich in fibre and fermented foods by breastfeeding mothers can affect the bacteria residing in the gut of their breastfed babies. The study will also explore how this diet affects the mother's gut microbiota, breast milk composition, and gastrointestinal (GI) symptoms for both mothers and babies. The main question of the study is: Does a 2-week diet high in fibre and fermented foods consumed by breastfeeding mothers affect the gut microbiota of their breastfed babies aged 2 to 5 months, compared to mothers following their habitual diet? Participants will: * Be randomly assigned to one of two groups: (1) one group will follow a specific diet high in fibre and fermented foods (25 g of fibre/day + 3 servings of fermented foods/day) in addition to their habitual diet, or (2) the second group will continue with their habitual diet (no specific foods will be provided) (16 g of fibre/day). * Attend a single study visit at the study location. * Provide body measurements (weight and height) of mothers and babies at the. study visit, and provide weight only during each home visit. * Complete gut health questionnaires for both mothers and babies twice during the study. * Complete two sets of 3-day, 24-hour dietary recalls during the study. * Provide stool samples (3 from babies and 2 from mothers) and 2 breast milk samples. Researchers will then compare the stool samples from both mothers and babies to see whether the specific diet makes any difference to the gut microbiota.

Eligibility Criteria

Inclusion Criteria: * Healthy breastfeeding women aged 18 years old and older. * Healthy singleton full-term infants (girls and boys) aged between 2 and 5 months old and who are exclusively breastfed. * Not using lifelong medications and antibiotics in the past 12 weeks prior to the study. * Not using prebiotic or probiotic supplements in the past 4 weeks prior to the study. * No serious problems preventing participants from breastfeeding their babies. * No food allergies or intolerances. * No chronic conditions like diabetes, cancer, heart disease, bowel disorders, eating disorders, or any illness requiring regular medical care or lifelong medication. * No history of complications during pregnancy (e.g., preeclampsia and gestational diabetes). Exclusion Criteria: * Expecting two or more children (i.e., multiple births; twins, triplets). * Not exclusively breastfeeding their infants (i.e., introduced formula or solids) or having medical conditions known to contraindicate breastfeeding (e.g., classic galactosemia, human immunodeficiency virus (HIV-virus) infection, untreated tuberculosis (TB)). * Preterm birth. * Clinically diagnosed with chronic medical conditions (e.g., type 1 and type 2 diabetes mellitus, cancer, cardiovascular diseases, and mental illnesses). * Medical conditions affecting gastric digestion or absorption (e.g., inflammatory bowel diseases (IBD), and irritable bowel syndrome (IBS)). * Conditions interfering with intervention intake (e.g., celiac disease, gluten hypersensitivity or lactose intolerance). * History of gestational complications. * Use of antibiotics in the past 12 weeks prior to the study. * Use of prebiotic or probiotic supplements in the past 4 weeks prior to the study. * Following exclusionary or restrictive diets (e.g., gluten-free, or weight loss).

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