Effect of a Nutritional Supplement on Gut Microbiota in Adults

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Pharmavite LLC
Study ID
NCT06611215
Status
Not Yet Recruiting

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Conditions

  • Changes in Gut Microbiota with Prebiotic Supplementation
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Treatment — DIETARY_SUPPLEMENT
    Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning
  • Placebo — DIETARY_SUPPLEMENT
    Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning
  • Treatment — DIETARY_SUPPLEMENT
    Prebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning
  • Placebo — DIETARY_SUPPLEMENT
    Placebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning

Study Details

According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.

Key Dates

Start date
Sep 23, 2024
Status verified
Sep 2024
Primary completion
Apr 7, 2025
Completion
Jun 2, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Prebiotic 1
  • Placebo Comparator: Placebo 1
  • Experimental: Prebiotic 2
  • Placebo Comparator: Placebo 2

Primary Outcome Measure

To evaluate the effect of eight weeks consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at the end of 8 week intervention [ Time Frame: From baseline to Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlantia Clinical Trials, 142 E Ontario StChicagoIllinois60611
Kevin O'Regan, Operations Manager
[email protected]
312-535-9440

Find similar trials in Chicago, IL

By research site
Atlantia Clinical Trials, 142 E Ontario St· Chicago, IL

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