Actively Recruiting

Phase Not Applicable
Age: 2Months - 45Years
All Genders
Healthy Volunteers
NCT06977113

Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome

Led by University of Glasgow · Updated on 2025-06-24

56

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome

Who Can Participate

Age: 2Months - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy breastfeeding women aged 18 years old and older.
  • Healthy singleton full-term infants aged between 2 and 5 months old who are exclusively breastfed.
  • No use of lifelong medications and no antibiotics in the past 12 weeks prior to the study.
  • No use of prebiotic or probiotic supplements in the past 4 weeks prior to the study.
  • No serious problems preventing breastfeeding.
  • No food allergies or intolerances.
  • No chronic conditions like diabetes, cancer, heart disease, bowel disorders, or eating disorders.
  • No history of pregnancy complications such as preeclampsia or gestational diabetes.
Not Eligible

You will not qualify if you...

  • Expecting twins, triplets, or other multiple births.
  • Not exclusively breastfeeding or having medical conditions that contraindicate breastfeeding like galactosemia, HIV infection, or untreated tuberculosis.
  • Preterm birth.
  • Diagnosed chronic medical conditions such as diabetes, cancer, cardiovascular diseases, or mental illnesses.
  • Medical conditions affecting digestion or absorption like inflammatory bowel disease or irritable bowel syndrome.
  • Conditions interfering with diet intake like celiac disease, gluten hypersensitivity, or lactose intolerance.
  • History of gestational complications.
  • Use of antibiotics in the past 12 weeks.
  • Use of prebiotic or probiotic supplements in the past 4 weeks.
  • Following restrictive diets such as gluten-free or weight loss diets.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Human Nutrition, School of Medicine, University of Glasgow

Glasgow, Scotland, United Kingdom, G31 2ER

Actively Recruiting

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Research Team

N

Nour Rizq, MSc

CONTACT

A

Ada Garcia, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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