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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2023
Source Kyowa Hakko Bio Co., Ltd.
Contact Eri Nakazaki, PhD
Phone +818071285540
Email eri.nakazaki@kyowa-kirin.co.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Dietary Supplement:
Placebo
Consume placebo (Maltodextrin) once daily before going to bed for 28 days
HMO 1
Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days
HMO 2
Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days

Locations

Country Name City State
Singapore Singapore Institute for Clinical Trials Singapore

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Hakko Bio Co., Ltd.

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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

Outcome

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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