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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.
The current study aims to investigate the effects of a 4-week intervention with two HMOs on gut microbiome composition, immune function and gastrointestinal symptoms in healthy adults with mild to moderate gastrointestinal complaints. The study will be conducted as a partially decentralized, double-blind, randomized, placebo-controlled, parallel group design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| HMO 1 | Experimental |
| |
| HMO 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Consume placebo (Maltodextrin) once daily before going to bed for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of Bifidobacterium in the gut | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of other bacterial taxa in the gut | 4 weeks | |
| Gut microbiome functional potential (functional metagenomics analyses) | 4 weeks | |
| Stool Human Milk Oligossacharides level |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptoms Questionnaire | 4 weeks | |
| Depression Anxiety Stress Scale (DASS)-21 items | 4 weeks | |
| Digestion-associated Quality of Life Questionnaire (DQLQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Institute for Clinical Trials | Singapore | 117609 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35040200 | Background | 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. | |
| 27719686 | Background | 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. |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| HMO 1 | Dietary Supplement | Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days |
|
| HMO 2 | Dietary Supplement | Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days |
|
| 4 weeks |
| Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel) | 4 weeks |
| 4 weeks |
| Bristol stool chart | Stool consistency ranging from Type 1 to Type 7 | 4 weeks |
| Clinical chemistry and haematology analyses for safety analysis | 4 weeks |