Clinical trial NCT06094153: Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Official title: Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Gastrointestinal Diseases
Keywords: Prebiotics
Lead sponsor: Kyowa Hakko Bio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative abundance of Bifidobacterium in the gut
timeFrame: 4 weeks
Secondary outcomes:
measure: Relative abundance of other bacterial taxa in the gut
timeFrame: 4 weeks
measure: Gut microbiome functional potential (functional metagenomics analyses)
timeFrame: 4 weeks
measure: Stool Human Milk Oligossacharides level
timeFrame: 4 weeks
measure: Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)
timeFrame: 4 weeks
Other outcomes:
measure: Gastrointestinal Symptoms Questionnaire
timeFrame: 4 weeks
measure: Depression Anxiety Stress Scale (DASS)-21 items
timeFrame: 4 weeks
measure: Digestion-associated Quality of Life Questionnaire (DQLQ)
timeFrame: 4 weeks
measure: Bristol stool chart
timeFrame: 4 weeks
measure: Clinical chemistry and haematology analyses for safety analysis
timeFrame: 4 weeks
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute for Clinical Trials
Study officials:
References:
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.
citation: 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.