Effect of a Nutritional Supplement on Gut Microbiota in Adults

Starting soon · Not applicable · Has a placebo group

Conditions studied: Changes in Gut Microbiota with Prebiotic Supplementation, Quality of Life

In brief

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 facts

Study ID

NCT06611215

Run by

Pharmavite LLC

People needed

80

Starts

2024-09-23

Expected to finish

2025-06-02

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible for inclusion, the Participant must fulfil all the following criteria:
• Be able to give written informed consent.
• Be between 18-60 years inclusive.
• BMI between 18.5 - 29.9kg/m2
• Is in general good health, as determined by the investigator.
• Consume less than 18g fiber per day.
• Maintain current dietary habits and physical activity levels.
• Willing to consume the Study Product for the duration of the study.

You may not qualify if…

• Participants will be excluded from the study if they meet any of the following criteria:
• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
• b. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
• c. Sexual partner(s) is/are exclusively female. d. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
• e. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
• Participants who are on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication at the time of screening.
• Participants with a current or history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
• Change in medications or supplements, or major dietary changes within 90 days of visit 1, or planning to do so during the study. This includes planning to start any new medications, herbals, or supplements.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history including but not limited to:
• Immunocompromised individuals (HIV/AIDS, chemo/radiation)
• Significant psychiatric disease (bipolar, schizophrenia, severe depression. Mild to Moderate depression stable on low dose medications \>3 months may be considered eligible in the opinion of the investigator).
• Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications including but not limited to:
• Anti-infectives (including antibiotics/antifungals. HIV prophylaxis is acceptable) within the 90 days prior visit 1 and for the duration of study.
• Steroids (inhaled, oral, or injected. Topical PRN use is acceptable) within the 28 days prior to visit 1 and for duration of study.
• Antipsychotic, Anxiolytics, hypnotics.
• Anticonvulsants.
• Prescribed sleeping medications
• Anti-rejection Medications
• Opioid pain relievers
• Current or recent use of prohibited foods and nutritional or non-nutritional supplements, including:
• a. Probiotics, Prebiotics, Post biotics and other fermented foods within the 28 days prior to visit 1. (Yogurt, kefir, kombucha) and for the duration of the study.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be receiving treatment involving experimental drugs/supplements. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

Where it is running

• Atlantia Clinical Trials, 142 E Ontario St — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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