Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

Healthy Clinical Trial

Official title:

Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094153
• Other study ID #: 2023-005
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Healthy

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