Status:
RECRUITING
Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
Lead Sponsor:
University of Glasgow
Conditions:
Healthy Mothers
Healthy Infants
Eligibility:
All Genders
2-45 years
Phase:
NA
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 oligosacc...
Detailed Description
Study duration: The study will span a total of three weeks, comprising a one-week run-in period followed by a two-week intervention period. Recruitment: Healthy, exclusively breastfeeding women age...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06977113
Start Date
March 11 2025
End Date
May 1 2028
Last Update
June 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Nutrition, School of Medicine, University of Glasgow
Glasgow, Scotland, United Kingdom, G31 2ER