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New treatment option for Healthy Mothers
Official title Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
ClinicalTrials.gov ID: NCT06977113
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 45. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
- Preterm birth.
- Clinically diagnosed with chronic medical conditions (e.g., type 1 and type 2 diabetes mellitus, cancer, cardiovascular diseases, and mental...
- 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).
See the full eligibility 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).
- 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)...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Glasgow, Scotland, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glasgow, Scotland, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.