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NCT06615986 · ClinicalTrials.gov registry record · Early Phase 1
Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
A Early Phase 1 study of Healthy Volunteers, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06615986: Recruiting Early Phase 1 study of Healthy Volunteers, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT06615986 is a Early Phase 1 study of Healthy Volunteers that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 100 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06615986, a Early Phase 1 study of Healthy Volunteers, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health. Objective: To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk. Eligibility: Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions). Design: Participants will have 2 clinic visits. The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study. Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person. The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal. The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
Primary Outcome
To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Cardiosyn
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-11-15 |
| Est. Completion | 2027-05-15 |
| Phase | Early Phase 1 |
What NCT06615986 shows while recruiting
NCT06615986 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Cardiosyn is the first listed.
NCT06615986 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06615986 about?
NCT06615986 is a clinical study titled "Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis". Background: Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. S...
What is the current status of trial NCT06615986?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2024-11-15. Estimated completion is 2027-05-15.
What conditions does trial NCT06615986 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06615986?
The interventions under investigation include: Cardiosyn (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06615986?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06615986 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06615986's enrollment target sits among peer trials
100 78th of 283 higher than 204 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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