COMPLETED

Effects of Immulina TM Supplements With PASC Patients

Conditions

Post Acute COVID-19 Syndrome Immulina Inflammation Natural Dietary Supplement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-site study that will try to determine the effects of Immulina ™, a natural dietary supplement, on blood chemicals associated with inflammation that are often increased in patients with long COVID (also called PASC).

Official Title

Effect of Immulina Supplements on Inflammatory Biomarkers Correlated With Clinical Symptoms in Patients With Long COVID (PASC)

Quick Facts

Study Start:2023-07-20

Study Completion:2025-07-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05524532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females, 18 to 99 years old * If female of child bearing potential, using acceptable means of birth control or postmenopausal for at least two years * Body temperature between 36.1°C and 37.7°C. * Has completed the 4-week washout period (if applicable), i.e., has refrained from using internally-consumed dietary supplements prior to Study Day 1 and through the completion of the study * A minimum of 2 hours fasting (except water) prior to all of the blood draws * Willing and able (in the opinion of study staff) to comply with all study requirements, including swallowing size 4 capsules (approximately 0.5" long and 0.25" diameter) and having phlebotomy * Good written and verbal English skills; able to follow instructions (in the investigator's opinion) * Not participating in a clinical study, currently or within the last 30 days * Signed informed consent	* Pregnant or lactating * Digestive tract disorders or conditions, such as (but are not limited to): ulcers, ulcerative colitis, Crohn's disease, gastric bypass, colostomy, ischemic colitis, gastroesophageal reflux disease (GERD), irritable bowel disease (IBD), diverticulitis that would be expected to impact on the oral disposition of the Immulina dietary supplement * Existence of any surgical and/or medical condition, significant disease or disorder, or any finding that may, in the judgment of the investigator, put the volunteer at risk or compromise study participation. * Any blood-thinning or clotting concomitant medication (prescription anticoagulants) * Donation or loss of 400 mL or more of blood within 8 weeks of Study Day 1 or unwilling to abstain from donation of blood during the study * Known or suspected allergy or sensitivity to Immulina, cellulose * History of drug or alcohol abuse within the last 12 months

Inclusion Criteria

Exclusion Criteria

* Males and females, 18 to 99 years old
* If female of child bearing potential, using acceptable means of birth control or postmenopausal for at least two years
* Body temperature between 36.1°C and 37.7°C.
* Has completed the 4-week washout period (if applicable), i.e., has refrained from using internally-consumed dietary supplements prior to Study Day 1 and through the completion of the study
* A minimum of 2 hours fasting (except water) prior to all of the blood draws
* Willing and able (in the opinion of study staff) to comply with all study requirements, including swallowing size 4 capsules (approximately 0.5" long and 0.25" diameter) and having phlebotomy
* Good written and verbal English skills; able to follow instructions (in the investigator's opinion)
* Not participating in a clinical study, currently or within the last 30 days
* Signed informed consent

* Pregnant or lactating
* Digestive tract disorders or conditions, such as (but are not limited to): ulcers, ulcerative colitis, Crohn's disease, gastric bypass, colostomy, ischemic colitis, gastroesophageal reflux disease (GERD), irritable bowel disease (IBD), diverticulitis that would be expected to impact on the oral disposition of the Immulina dietary supplement
* Existence of any surgical and/or medical condition, significant disease or disorder, or any finding that may, in the judgment of the investigator, put the volunteer at risk or compromise study participation.
* Any blood-thinning or clotting concomitant medication (prescription anticoagulants)
* Donation or loss of 400 mL or more of blood within 8 weeks of Study Day 1 or unwilling to abstain from donation of blood during the study
* Known or suspected allergy or sensitivity to Immulina, cellulose
* History of drug or alcohol abuse within the last 12 months

Contacts and Locations

Principal Investigator

Gailen D Marshall, Jr., MD, PhD

PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Study Locations (Sites)

University of Hawaii

Honolulu, Hawaii, 96813

United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808

United States

Louisiana State University

New Orleans, Louisiana, 70112

United States

MaineHealth

Portland, Maine, 04101

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

West Virginia University

Morgantown, Virginia, 26506

United States

Collaborators and Investigators

Sponsor: University of Mississippi Medical Center

Gailen D Marshall, Jr., MD, PhD, PRINCIPAL_INVESTIGATOR, University of Mississippi Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20

Study Completion Date2025-07-29

Study Record Updates

Study Start Date2023-07-20

Study Completion Date2025-07-29

Terms related to this study

Keywords Provided by Researchers

Immulina
Post Acute Covid-19 Syndrome
Inflammation
Natural Dietary Supplement

Additional Relevant MeSH Terms

Post Acute COVID-19 Syndrome