- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141903
Dietary Supplement With and Without a Probiotic and/or Antibiotic
August 13, 2022 updated by: Prolacta Bioscience
Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment in Healthy Volunteers
Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others.
The synergy with a probiotic may enhance gastrointestinal colonization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers who have received antibiotics. The combination should support general gastrointestinal health.
This study is a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 50 healthy adult volunteers ages 18-75.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- Altasciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy Adults, ages 18-75.
Description
Inclusion Criteria:
- Healthy adults between the ages of 18-75 years (subjects must be 18-75 at the time of consent) who can provide proof of vaccination against SARS-CoV-2. Proof may be a physical or electronic record of vaccination or self-attestation (to include approximate vaccination date and manufacturer of vaccine) if a copy of the vaccination record is not available
- Subjects must have a BMI of 18 - 30 at screening visit
- Willingness to complete study specific questionnaires
- Willingness to complete journal to record IP dosing times, Bristol stool scores, and IP flavor questionnaires
- Willingness to complete all study procedures, clinic visits, and provide required biospecimen samples
- Willingness to collect and process stool samples at home and transport stool samples to clinic
- Sexually active females of child-bearing potential must agree to use highly effective methods of contraception during heterosexual intercourse throughout the study period and for three days following discontinuation of IP, whichever comes later. Examples of highly effective methods include the use of two forms of contraception with one being an effective barrier method (e.g., a condom and spermicide used together), or have a vasectomised partner. Abstinence is acceptable as a life-style choice. Female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
- Provide informed consent
Exclusion Criteria:
- Subjects with a BMI of 17 or less or 31 or greater are excluded
- Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
- Subjects who intend to take a probiotic during the study
- Subjects with self-reported diarrhea on day 1 prior to dosing, whereby diarrhea is defined as two or more episodes of watery and/or unformed stool within 24 hours
- Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening and day 1 of the study
- Unstable medical condition, in the opinion of the investigator
- Subject with a history of allergy to the study antibiotics
- Clinically significant abnormal laboratory test results at screening
- Subjects who are unable or unwilling to provide stool samples on a regular basis as per study protocol
- Participation in a clinical research trial within 30 days prior to screening
- Unable to give informed consent
- Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
- Known carriers of C. difficile prior to study start, as determined by qPCR of stool
- Known carriers of vancomycin-resistant enterococci (VRE) prior to study start, as determined by stool culture
- Subjects with history of lactose intolerance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arm 1
Antibiotic conditioning
|
Dietary supplement, probiotic, antibiotic conditioning -all groups
|
Arm 2
Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.
|
Dietary supplement, probiotic, antibiotic conditioning -all groups
|
Arm 3
Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.
|
Dietary supplement, probiotic, antibiotic conditioning -all groups
|
Arm 4
Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.
|
Dietary supplement, probiotic, antibiotic conditioning -all groups
|
Arm 5
Antibiotic conditioning and probiotic treatment.
|
Dietary supplement, probiotic, antibiotic conditioning -all groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary outcomes
Time Frame: 35 days
|
Evaluation of the changes in microbiome species abundance and diversity from baseline until end of study.
|
35 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcomes
Time Frame: 35 days
|
Blood parameters, such as cytokine levels
|
35 days
|
Secondary Outcomes
Time Frame: 35 days
|
Safety assessment
|
35 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2021
Primary Completion (Actual)
May 23, 2022
Study Completion (Actual)
June 9, 2022
Study Registration Dates
First Submitted
November 19, 2021
First Submitted That Met QC Criteria
November 19, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 13, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-CT-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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