Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
Launched by UNIVERSITY OF GLASGOW · May 8, 2025
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how the diet of breastfeeding mothers can affect the gut bacteria in their babies. Researchers want to find out if a two-week diet that is high in fiber and includes fermented foods, like yogurt and kefir, can change the gut microbiota of breastfed babies aged 2 to 5 months compared to mothers who continue their usual diet. The gut microbiota is important for a baby’s overall health, and the sugars in breast milk, which are influenced by a mother's diet, play a role in developing a healthy gut.
To participate in the study, mothers need to be healthy and at least 18 years old, and their babies should be full-term, healthy infants who are exclusively breastfed and between 2 to 5 months old. During the study, participants will be assigned to either follow the high-fiber fermented diet or continue their regular diet. They will attend a visit to provide body measurements, answer questionnaires about gut health, share their food intake for a few days, and give stool and breast milk samples. This research aims to help understand how diet influences both mothers and their babies during breastfeeding.
Gender
ALL
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).
About University Of Glasgow
The University of Glasgow is a prestigious academic institution renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive expertise in various fields of medicine and health sciences to design and conduct innovative clinical trials. With a strong focus on ethical standards and patient safety, the University of Glasgow collaborates with multidisciplinary teams and partners to translate research findings into practical applications, fostering advancements in medical knowledge and therapeutic interventions. Its dedication to excellence in research and education positions the university as a leader in clinical trial initiatives that aim to address pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Glasgow, Scotland, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported