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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flaxseed | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flaxseed | Dietary Supplement | Flaxseed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Patient reported pain outcomes will be assessed weekly with pain scores and end of the study with quality of life measures | 4 weeks |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chinenye R Dike, MD MS | Contact | 205 638 9918 | cdike@uabmc.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36904244 | Result | Dike CR, Lebensburger J, Mitchell C, Darnell B, Morrow CD, Demark-Wahnefried W. Palatability and Acceptability of Flaxseed-Supplemented Foods in Children with Sickle Cell Disease. Nutrients. 2023 Mar 1;15(5):1245. doi: 10.3390/nu15051245. | |
| 33275672 | Result | Osunkwo I, O'Connor HF, Saah E. Optimizing the management of chronic pain in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):562-569. doi: 10.1182/hematology.2020000143. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D008043 | Linseed Oil |
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 |
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| 21584938 | Result | Raphael JL, Mei M, Mueller BU, Giordano T. High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease. Pediatr Blood Cancer. 2012 Apr;58(4):584-90. doi: 10.1002/pbc.23181. Epub 2011 May 16. |
| 31730182 | Result | Lubeck D, Agodoa I, Bhakta N, Danese M, Pappu K, Howard R, Gleeson M, Halperin M, Lanzkron S. Estimated Life Expectancy and Income of Patients With Sickle Cell Disease Compared With Those Without Sickle Cell Disease. JAMA Netw Open. 2019 Nov 1;2(11):e1915374. doi: 10.1001/jamanetworkopen.2019.15374. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |