Healthy Clinical Trial
Official title:
Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
NCT number | NCT06094153 |
Other study ID # | 2023-005 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 4, 2023 |
Est. completion date | July 2024 |
Human Milk Oligosaccharides (HMOs) are the third most abundant class of nutrients in human milk. Studies investigating the effects of dietary HMOs in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial Bifidobacterium, Lactobacillus, and Bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. Only a limited number of studies have been conducted in adults, showing intake of HMOs stimulates the growth of gut Bifidobacterium in healthy adults.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 55 Years |
Eligibility | Inclusion Criteria: - Age = 40 and = 55 years - Male/female - Total score of >2 on the Gastrointestinal Symptom Rating Scale (GSRS) - Body Mass Index 18-30 kg/m2 - Stable body weight (± 5%) for at least 6 months - Stable lifestyle and dietary habits within the 4 weeks prior and during study period - Owns device (computer, smartphone, tablet) with access to the internet - Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments - Sufficient vision and hearing to complete study procedures - Willing and able to participate, follow the study procedures and to give written informed consent Exclusion Criteria: - History (< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery - Current or past (< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on GI system or on visceral motility - Having received antibiotic treatment < 4 weeks prior to study - Alcohol intake >1 units/day - Currently pregnant or pregnancy in past 6 months - Use of pro/prebiotics < 4 weeks prior to study start - Fully vegetarian/vegan diet < 4 weeks prior to study start - High habitual vegetable and fruit intake (> 2 servings of fruits and >2 servings of vegetables per day) < 4 weeks prior to study start - Lactose intolerance - Maltodextrin allergy - Members of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore Institute for Clinical Trials | Singapore |
Lead Sponsor | Collaborator |
---|---|
Kyowa Hakko Bio Co., Ltd. |
Singapore,
Elison E, Vigsnaes LK, Rindom Krogsgaard L, Rasmussen J, Sorensen N, McConnell B, Hennet T, Sommer MO, Bytzer P. Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr. 2016 Oct;116(8):1356-1368. doi: 10.1017/S0007114516003354. Epub 2016 Oct 10. — View Citation
Sprenger N, Tytgat HLP, Binia A, Austin S, Singhal A. Biology of human milk oligosaccharides: From basic science to clinical evidence. J Hum Nutr Diet. 2022 Apr;35(2):280-299. doi: 10.1111/jhn.12990. Epub 2022 Feb 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gastrointestinal Symptoms Questionnaire | 4 weeks | ||
Other | Depression Anxiety Stress Scale (DASS)-21 items | 4 weeks | ||
Other | Digestion-associated Quality of Life Questionnaire (DQLQ) | 4 weeks | ||
Other | Bristol stool chart | Stool consistency ranging from Type 1 to Type 7 | 4 weeks | |
Other | Clinical chemistry and haematology analyses for safety analysis | 4 weeks | ||
Primary | Relative abundance of Bifidobacterium in the gut | 4 weeks | ||
Secondary | Relative abundance of other bacterial taxa in the gut | 4 weeks | ||
Secondary | Gut microbiome functional potential (functional metagenomics analyses) | 4 weeks | ||
Secondary | Stool Human Milk Oligossacharides level | 4 weeks | ||
Secondary | Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel) | 4 weeks |
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