Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Официальное название

Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Обзор

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.

Подробное описание

Study Description:

This pilot proof-of-principle (PoP) study will investigate mechanisms of action of a human milk oligosaccharide (HMO)-based synbiotic supplement, Cardiosyn (a combination of prebiotics and pro-biotics). Synbiotics for gut microbiota are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions, and normalizing blood lipids and iron markers in healthy human subjects.

Objectives:

Primary Objective:

To measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.

Secondary Objectives:

Measure the level of adherence to the symbiotic supplementation.

Measure the effect of the synbiotic supplementation in plasma.

Measure the effect of synbiotic supplementation on gut integrity.

Tolerability and GI symptoms secondary to gut microbiome changes.

Tertiary/Exploratory Objectives:

Identify possible associations between the gut microbiome change and biomarkers.

Endpoints: Primary Endpoint:

At least an increase in the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.

Secondary Endpoint:

Reported intake by the subject and counting the number of the remaining supplement

Biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin, lipid profile and TMAO

Measurement of gut integrity marker (serum zonulin) in plasma

Number of participants that tolerated study supplement for full duration of study

Number of participants with GI reported symptoms according to CTCAE v5.0

Tertiary/Exploratory Endpoints:

Measurement of changes of microbiome and biomarkers in plasma (16S RNA microbiota analysis initially with potential for more extensive and novel analysis).

Вмешательства

• Пищевая добавка Cardiosyn
  Two sachets by mouth daily. Each dose (sachet) is 8.1 grams. For 2 doses it will be 16.2 grams per person per day.

Первичные конечные точки

• Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum [Срок оценки: 8 weeks]

Вторичные конечные точки (5)

• Reported intake by the subject and counting the number of remaining supplement [Срок оценки: 8 weeks]
• Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma [Срок оценки: 8 weeks]
• Fold increase in Lactobacillus or Bifidobacterium over baseline [Срок оценки: 8 weeks]
• Number of participants that tolerated symbiotic supllementation [Срок оценки: 8 weeks]
• Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0 [Срок оценки: 8 weeks]

Критерии участия

• INCLUSION CRITERIA:
• Healthy males and females between the ages 18 to 99.
• Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
• Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion).
• Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.

Критерии исключения

• Pregnancy or women currently breastfeeding.
• Subjects currently on other prebiotics and/or probiotics supplementation.
• Subjects that are vegetarians or vegans or not on a typical western diet.
• Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
• Subjects with allergy or known hypersensitivity to any components of the supplement.
• Subjects with weight changes greater than 20% over the past 3 months.
• Subjects planning a significant change in diet or exercise levels.
• Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
• Anticipated surgery during the study period.
• Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT06615986 · 10001729 · 001729-H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗