The Effect of Maternal High Fibre and Fermented Food Rich Diet on Breastfed Infant Gut Microbiome: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Gut Microbiota and Short Chain Fatty Acids of Breastfed Infants after 2-week Dietary Intervention
研究概览
简要总结
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.
详细描述
Study duration:
The study will span a total of three weeks, comprising a one-week run-in period followed by a two-week intervention period.
Recruitment:
Healthy, exclusively breastfeeding women aged over 18 years and their healthy infants aged between 2 to 5 months will be recruited from the general population residing in the Glasgow & Clyde area of Scotland. The study will be advertised using posters distributed through various channels, including word of mouth, breastfeeding support groups, schemes, venues, and organisations, as well as social media platforms. Researchers will screen potential participants for eligibility and only recruit healthy participants (i.e., healthy mothers and infants). Eligible participants will be invited to attend a one-hour study visit at the researchers' metabolic facilities for further screening.
Study visit:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 2 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
High Fibre Fermented Food Diet
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.
干预措施: High Fibre Fermented Food Diet (Other)
Control Habitual Diet
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).
干预措施: Control Habitual Diet (Other)
结局指标
主要结局
Gut Microbiota and Short Chain Fatty Acids of Breastfed Infants after 2-week Dietary Intervention
时间窗: From enrolment to the end of intervention at 3 weeks
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.
次要结局
- Maternal Gut Microbiota and Microbial Metabolites and Breast Milk Composition(From enrolment to the end of intervention at 3 weeks)
研究者
Ada Garcia
Senior Lecturer in Public Health Nutrition, School of Medicine, Dentistry & Nursing
University of Glasgow