Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
NCT06977113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-06-24
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.
Conditions
- Healthy Mothers
- Healthy Infants
Interventions
- OTHER
-
High Fibre Fermented Food Diet
Participants will be provided with and asked to consume specific foods high in various types of fibre to promote a variety of substrates for gut bacteria including inulin, galactooligosaccharides (GOS), and β-glucan. Participants will also be asked to consume 2 fermented items, yogurt and kefir. Study foods will be commercially available including a high-fibre bar made from chicory-derived inulin (1 bar of 35 g/d), oat-containing cakes (4 oatcakes of 35 g/d) or oat porridge (1 sachet of 38.5 g/d), shredded wheat cereal biscuits (2 biscuits of 45 g/d), hummus (½ pot of 100 g/d), and/or baked beans (½ can of 100 g/d) or lentil soup (1 can of 400 g/d), and low fat yogurt (1/3 pot of 150 g/d) and kefir (½ bottle of 250 ml/d). The total amount of fibre study foods will provide is approximately 25 g/day which will be consumed in addition to the habitual diet. The total amount of fibre will be expected to reach the 30 g/day recommendation and will range between 25 - 40 g/day.
- OTHER
-
Control Habitual Diet
Participants will follow their habitual diet and will not consume any of the study foods (i.e., high-fibre fermented foods). The population average fibre intake for women in Scotland is 16 g/day (The Scottish Health Survey 2021).
Sponsors & Collaborators
-
University of Glasgow
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Months
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-11
- Primary Completion
- 2026-12-31
- Completion
- 2028-05-31
Countries
- United Kingdom
Study Locations
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