Sickle Cell Disease (SCD)
Conditions
Keywords
Nutritional trial, sickle cell disease, children
Brief summary
The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD).
Detailed description
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Acute pain is the most frequent cause of hospitalization in children. Pain in sickle cell disease is inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Our preliminary study showed that gut dysbiosis is linked to pain. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with SCD. Acceptance of fish oil varies given its fishy smell and taste. Flaxseed is a plant-based omega-3-fatty acid which has antioxidant and anti-inflammatory properties. This study aims to conduct a feasibility trial on the use of flaxseed to modulating the gut microbiome and improving inflammatory markers and pain outcomes in children with SCD.
Interventions
DIETARY_SUPPLEMENTFlaxseed
Flaxseed
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- Children 5-18 years with SCD at steady state. Steady state will be defined as not requiring an acute care visit for pain in the last 28 days.
Exclusion criteria
* current use of antibiotics except prophylactic penicillin * current use of pre-or probiotic supplements * current use of PPI therapy * pregnant or lactating females * individuals with known allergy to Flaxseed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 4 weeks | Participants will be asked to complete electronic adherence dairies- Feasibility will be defined by more than 50% of enrolled participants eating flaxseed at least 5 days a week for the study duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 4 weeks | Patient reported pain outcomes will be assessed weekly with pain scores and end of the study with quality of life measures |
Contacts
CONTACTChinenye R Dike, MD MS
Outcome results
None listed