Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults

University of North Carolina (UNC)

Status: Completed

Conditions: Intestinal Health

Treatments: Other: Matching Placebo; Dietary Supplement: Galacto-oligosaccharides (GOS); Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06068894

21-2453

Details and patient eligibility

About

This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32.

• Individuals must be able to give informed consent.

• Subjects willing and able to:

  • consume prebiotics or placebo preparations for a period of 4 weeks.
  • Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.
  • provide stool and blood (via venipuncture) samples.

• Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.

Exclusion criteria

• Less than 18 years of age or older than 55 years of age
• Pregnant or breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS)

Experimental group

Description:

The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.

Treatment:

Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS)

galacto-oligosaccharides (GOS)

Experimental group

Description:

The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.

Treatment:

Dietary Supplement: Galacto-oligosaccharides (GOS)

Placebo

Placebo Comparator group

Description:

The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.

Treatment:

Other: Matching Placebo