Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome

NCT06977113 | Recruiting

• 1 other identifier: 200240089
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 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

Keywords

maternal diet; breast milk; infant gut microbiome; dietary fibre; fermented food; human milk oligosccharide; short chain fatty acids; gut microbiota; Exclusive breastfeeding

Outcome Measures

Primary Outcomes (1)

• Gut Microbiota and Short Chain Fatty Acids of Breastfed Infants after 2-week Dietary Intervention

  The primary objective is to evaluate whether the maternal 2-week diet rich in fibre and fermented foods alters the composition of microbiota and short chain fatty acid (SCFA) level in the gut of breastfed infants. Microbiota composition will be assessed, following stool DNA extraction, through 16S rRNA amplicon sequencing and quantitative polymerase chain reaction (qPCR). SCFA will be quantified using gas chromatography (GC) and potentially other microbial derived metabolites will be measured using other analytical techniques.

  From enrolment to the end of intervention at 3 weeks

Secondary Outcomes (1)

• Maternal Gut Microbiota and Microbial Metabolites and Breast Milk Composition

  From enrolment to the end of intervention at 3 weeks

Study Arms (2)

High Fibre Fermented Food Diet

EXPERIMENTAL

Participants in this arm will be assigned to consume specific foods that are high in fibre and fermented products (25 g fibre/day) in addition to their usual diet for two weeks. These foods include oatcakes or oat porridge, shredded wheat cereal biscuits, a high-fibre bar, yogurt and kefir, as well as two of the following: hummus, lentil soup, or baked beans. These foods will only be consumed by the mothers and they will be instructed to eat specific portion sizes of each food item per day. Researchers will provide participants with a dietary checklist to help them record their daily intake of the study foods for the 2-week study period. Participants will be asked to avoid consuming probiotic and prebiotic supplements during the 2-week study intervention.

Other: High Fibre Fermented Food Diet

Control Habitual Diet

OTHER

Participants assigned to the control group will maintain their habitual diet, and they will not be given any of the study foods. Participants will be asked to avoid consuming probiotic and prebiotic supplements throughout the 2-week study period. The population average fibre intake for women in Scotland is 16 g/day (The Scottish Health Survey 2021).

Other: Control Habitual Diet

Interventions

High Fibre Fermented Food Diet OTHER

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.

High Fibre Fermented Food Diet

Control Habitual Diet OTHER

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).

Control Habitual Diet

Eligibility Criteria

• Age: 2 Months - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Human Nutrition, School of Medicine, University of Glasgow

Glasgow, Scotland, G31 2ER, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Nour Rizq, MSc

CONTACT

+44 141 956 0465; n.rizq.1@research.gla.ac.uk

Ada Garcia, PhD

CONTACT

+44 141 956 0465; ada.garcia@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study intervention, which involves the use of whole foods that cannot be effectively concealed, both study researchers and participants will be unblinded to group allocation during the intervention. However, to minimize bias and ensure objective evaluation, study researchers involved in data analysis will be blinded to the group assignments throughout the analysis process.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Public Health Nutrition, School of Medicine, Dentistry & Nursing

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)