Status:
ACTIVE_NOT_RECRUITING
Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Lead Sponsor:
Kyowa Hakko Bio Co., Ltd.
Conditions:
Healthy
Gastrointestinal Diseases
Eligibility:
All Genders
40-55 years
Phase:
NA
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 developmenta...
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 mod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06094153
Start Date
October 4 2023
End Date
September 1 2025
Last Update
February 5 2025
Active Locations (1)
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1
Singapore Institute for Clinical Trials
Singapore, Singapore, 117609