NCT07530965

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

March 16, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 16, 2026

Last Update Submit

April 8, 2026

Conditions

Sickle Cell Disease (SCD)

Keywords

Nutritional trialsickle cell diseasechildren

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Pain

    4 weeks

Study Arms (1)

Flaxseed

OTHER
Dietary Supplement: Flaxseed

Interventions

FlaxseedDIETARY_SUPPLEMENT

Flaxseed

Flaxseed

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Dike CR,Lebensburger J,Mitchell C,Darnell B,Morrow CD,Demark-Wahnefried W

    RESULT

  • Osunkwo I,O'Connor HF,Saah E

    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.

    PMID: 21584938RESULT

  • 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.

    PMID: 31730182RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

Chinenye R Dike, MD MS

CONTACT

205 638 9918cdike@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2026

First Posted

April 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04