Sheep and Cow Milk Complementary Food Effects on Gut Microbial Diversity - The SMILEY Pilot Study

Not Applicable

Recruiting

• Conditions: Gut microbiota; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000988651
• Lead Sponsor: The University of Auckland, Faculty of Medical and Health Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-11
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Infants will be eligible for participation in the study if they
- Are healthy
- Are between 3-6 months of age
- Were at least 32 weeks gestation at birth
- Are exclusively breastfed
- Will be introduced to their first complimentary foods at around 6 months of age, and not before 4 months of age, as per the New Zealand Ministry of Health Food and Nutrition Guidelines for Infants
- Have parents or legal guardians that can give written informed consent to participate in the study

Exclusion Criteria

Infants will not be eligible for participation if they:
- Were born <32 weeks gestation
- Were small for gestational age (as they may have special dietary requirements)
- Have a developmental disability (i.e., autism, intellectual disability)
- Have an illness likely to influence their nutritional status (e.g., a chronic illness known to cause malabsorption, any digestive or metabolic disorders)
- Have health conditions that affect feeding
- Are undergoing treatment with antibiotics
- Have had any complementary foods at recruitment
- Are receiving a supplement with a pre-and/or probiotic
- Are on infant formula
- Have parents or legal guardians whose written or spoken English comprehension is likely to make participation difficult.

Study & Design

• Study Type: Interventional
• Study Design: Not specified