Effect of a High Fibre Fermented Diet on Breastfed Infant Gut Microbiome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.