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Primary completion date changed from estimate of Apr 15, 2027 to Jul 28, 2026
Eligibility criteria expanded, about 15 words
Site details revised
Minor8 versionsRe-verified since Mar 14, 2025, no change to tracked fieldsv29-v36
MinorStudy description shortened, about 2 wordsv28
Minor3 versionsRe-verified since Dec 14, 2024, no change to tracked fieldsv25-v27
MinorStart date: Oct 29, 2024 to Nov 15, 2024v24
Show 22 earlier versionsHide 22 earlier versions
NotableTrial status: Not Yet Recruiting to Recruiting
Start date changed from estimate of Nov 4, 2024 to Oct 29, 2024
Site details revised
v23
MinorStart date: Nov 3, 2024 to Nov 4, 2024v22
MinorStart date: Oct 31, 2024 to Nov 3, 2024v21
MinorStart date: Oct 30, 2024 to Oct 31, 2024v20
MinorStart date: Oct 29, 2024 to Oct 30, 2024v19
MinorStart date: Oct 28, 2024 to Oct 29, 2024v18
MinorStart date: Oct 25, 2024 to Oct 28, 2024v17
MinorStart date: Oct 24, 2024 to Oct 25, 2024v16
MinorStart date: Oct 23, 2024 to Oct 24, 2024v15
MinorStart date: Oct 21, 2024 to Oct 23, 2024v14
MinorStart date: Oct 20, 2024 to Oct 21, 2024v13
MinorStart date: Oct 17, 2024 to Oct 20, 2024v12
MinorStart date: Oct 16, 2024 to Oct 17, 2024v11
MinorStart date: Oct 15, 2024 to Oct 16, 2024v10
MinorStart date: Oct 14, 2024 to Oct 15, 2024v9
MinorStart date: Oct 13, 2024 to Oct 14, 2024v8
MinorStart date: Oct 9, 2024 to Oct 13, 2024v7
MinorStart date: Oct 8, 2024 to Oct 9, 2024v6
MinorStart date: Oct 7, 2024 to Oct 8, 2024v5
MinorStart date: Oct 4, 2024 to Oct 7, 2024v4
MinorStart date: Oct 3, 2024 to Oct 4, 2024
Study description expanded, about 48 words
Eligibility criteria shortened, about 1 word
v3
MinorStart date: Oct 2, 2024 to Oct 3, 2024v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.