Effect of a High Fibre Fermented Diet on Breastfed Infant Gut Microbiome
The Effect of Maternal High Fibre and Fermented Food Rich Diet on Breastfed Infant Gut Microbiome: A Randomised Controlled Trial
This study is testing if a high fiber and fermented food diet for breastfeeding moms can positively affect the gut health of their infants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 2 Months to 45 Years |
| Sex | All |
| Sponsor | University of Glasgow Academic / other |
| Locations | 1 site (Glasgow, Scotland) |
| Trial ID | NCT06977113 on ClinicalTrials.gov |
What this trial studies
This study investigates how a diet rich in fiber and fermented foods consumed by breastfeeding mothers influences the gut microbiome of their infants. Over a total duration of three weeks, including a one-week run-in and a two-week intervention, healthy breastfeeding women aged 18 and older and their infants aged 2 to 5 months will be recruited from the Glasgow & Clyde area. Participants will be assigned to either a high fiber fermented food diet or a control habitual diet, and various assessments will be made regarding gut microbiota, breast milk composition, and gastrointestinal symptoms for both mothers and infants.
Who should consider this trial
Good fit: Ideal candidates include healthy breastfeeding women over 18 years old with healthy singleton infants aged 2 to 5 months who are exclusively breastfed.
Not a fit: Patients who have chronic conditions, food allergies, or are taking medications that affect gut health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how maternal diet impacts infant gut health, potentially leading to improved dietary recommendations for breastfeeding mothers.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that maternal diet can influence infant gut microbiota, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Glasgow, Scotland
- Human Nutrition, School of Medicine, University of Glasgow — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nour Rizq, MSc
- Email: n.rizq.1@research.gla.ac.uk
- Phone: +44 141 956 0465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.