The TUMMY Trial - The study of omega-3 supplementation in breast-feeding mums on gut health of their baby

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001447448
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: University of Adelaide
• Public title: The TUMMY Trial - The study of omega-3 supplementation in breast-feeding mums on gut health of their baby
• Scientific title: The study of omega-3 supplementation in breast-feeding mums on gut health of their baby
• Date of first enrolment: 01/11/2016
• Target sample size: 90
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001447448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Chloe Douglas

• Name: Ms Chloe Douglas

Key inclusion & exclusion criteria

Inclusion criteria: - Singleton pregnancy
- Intending to exclusively breastfeed for at least 12 weeks post-partum
- Willing to take capsules containing fish-oil
- Willing to attend a follow-up appointment at Flinders Medical Centre at 12 weeks post-partum (end of the intervention)

Exclusion criteria: - Known major fetal abnormalities
- Infants birth weight less than 2500 grams
- Caesarean section delivery
- Pre-term delivery (less than 37 completed weeks gestation)
- Taking high dose fish-oil supplements (providing equal to or more than 250mg DHA/day)
- Taking fish-oil supplements (providing less than 250mg DHA/day) and not willing to stop
- Bleeding disorder in which fish-oil is contraindicated
- Participation in other RCTs involving omega-3 LCPUFA supplementation during pregnancy


Age minimum: 16 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

Diet and Nutrition - Other diet and nutrition disorders

Reproductive Health and Childbirth - Breast feeding

Microbiome health;
Microbiome health

Intervention(s)

Intervention capsule (High omega-3 oil blend)
500mg capsule - 75mg of Eicosapentaenoic acid (EPA) and 250mg of docosahexaenoic acid (DHA) in the form of triglyceride
- each participant will be randomly assigned to either the control or intervention group
- participants will be asked to consume 4 oral capsules (500mg per capsule, 2000mg total/day) per day from randomisation to 12 weeks post-partum
Women will be asked to return unused supplements at 12 weeks post-partum when a spot blood sample is taken. The proportion of capsules returned will serve as a measure of adherence. DHA concentration at the end of intervention will be used as an independent biomarker of adherence.

Primary Outcome(s)

The primary outcome of the study is to determine whether increasing the supply of omega-3 LCPUFA, chiefly as DHA, to breast-fed term infants in the first 12 weeks after birth alters the composition of their gut microbiome, as indicated by an increase in species diversity and numbers of commensal bacteria (a composite outcome) in stool samples collected from the infants. [The composition of the microbiome will be assessed at 12 weeks after birth. Stool samples will also be collected within the first 7 days after birth (before the mother starts taking capsules) for the assessment of the microbiome at baseline. ]

Secondary Outcome(s)

The study will also establish if DHA supplementation in breast feeding women can improve gut maturation/immune profile (a composite outcome as determined by gene expression profile in epithelial cells isolated from stool samples) in the infants during the first 12 weeks after birth. [Gut maturation/immune profile will be assessed at 12 weeks after birth. Stool samples will also be collected within the first 7 days after birth (before the mother starts taking capsules) for the assessment of the gut maturation/immune profile (composite outcome) at baseline. ]

To determine the effect of increasing the supply of omega-3 LCPUFA, chiefly as DHA, to breast feeding women on the composition of the maternal gut microbiome (species diversity and numbers as a composition outcome) assessed using stool samples. [The composition of the maternal microbiome will be assessed at 12 weeks post-partum. Stool samples will also be collected within the first 7 days post-partum (before the mother starts taking capsules) for the assessment of the maternal microbiome at baseline. ]

The effect of increasing the supply of omega-3 LCPUFA, chiefly as DHA, to breast feeding women on the composition of the breast milk microbiome (species diversity and numbers as a composition outcome) assessed in breast milk samples.[The composition of the breastmilk microbiome will be at 12 weeks post-partum. Breast milk samples will also be collected within the first 7 days post-partum (before the mother starts taking capsules) for the assessment of the breast milk microbiome at baseline. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

BASF

Ethics review

Status: Approved
Approval date:
Contact:

Southern Adelaide Clinical Human Research Ethics Committee