Determination of the Safety and Efficacy of Two Probiotic Strains (CODECS)

June 17, 2024 updated by: The Archer-Daniels-Midland Company

Determination of the Safety and Efficacy of Two Probiotic Strains in Adults With Mild to Moderate Gastrointestinal Discomfort

The goal of this study is to determine the safety and efficacy of two probiotic strains in adults with mild to moderate gastrointestinal discomfort. The main questions it aims to answer is whether 6-week administration of a probiotic can improve how the participant feels regarding their gut health. This is done by completing a weekly questionnaire and the results are compared between the 6 weeks the participants are on a placebo and the 6 weeks the participants are on the probiotic. Participants will also provide a blood sample, and stool sample at the start and end of each treatment. Similarly, the results from the blood samples and stool samples will be analysed to determine if there is any improvement in markers related to gut health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this randomized, crossover, double-blind, prospective, placebo controlled study we aim to determine the safety and efficacy of two probiotic strains in adults with mild to moderate gastrointestinal discomfort. 100 healthy adults with subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 inclusive), 50 subjects per strain (test sequence). The GSRS-IBS (gastrointestinal symptom rating scale - irritable bowel syndrome) questionnaire ranges from 0-78 with a greater score indicating a higher occurrence of gastrointestinal symptoms. Safety: To evaluate adverse events that occur during the probiotic treatment period as compared to the placebo period. Incidence and duration of upper respiratory tract symptoms, urinary tract symptoms, gastrointestinal symptoms as primary outputs. Efficacy: To evaluate the effect of 6-week probiotic administration on gastrointestinal homeostasis using GSRS-IBS score as an index as compared to placebo. Following a screening period, participants will provide stool, urine (safety) and blood samples prior to commencing a 6 week course of either placebo or one of the probiotics. At this time participants will again provide blood and stool samples. Throughout the study participants will maintain a daily diary to note any unusual events and to report stool consistency using Bristol stool chart. The participants will also complete a once-weekly questionnaire (GSRS-IBS questionnaire) relating to gut health. There will then be a 3-week washout period where they will take no products. After these 3 weeks the participants will again provide a stool and blood samples, and as before maintain their daily diary and weekly questionnaire for 6 weeks while on the probiotic or placebo (they will have swapped at this point). After these 6 weeks the participants will again provide stool and blood samples.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed Informed consent form
  2. Healthy adults aged 18-65 years
  3. Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)

Exclusion Criteria:

  1. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
  2. Severe chronic illnesses
  3. Known immunodeficiency
  4. Use of immunosuppressive agents (corticosteroids, methotrexate…)
  5. Presence of severe immunodeficient family members as provided by subjects self-report
  6. Pregnancy, 6 months postpartum period or current breastfeeding
  7. Women of childbearing age planning pregnancy during the course of the study
  8. Actively participating in another clinical study, having completed a clinical study in the past 60 days or being in the exclusion period of a previous clinical study
  9. Not able to understand and comply with requirements of the study
  10. Use of probiotics, prebiotics, postbiotics, antibiotics within 3 weeks of study commencement

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Placebo 1 to Probiotic A
Sequence A1 (n=25): Placebo 1 administered daily for 42 days, followed by 21 days washout, then 1 x 10^9 colony forming units (CFU) of Probiotic A administered daily for 42 days
Dietary supplement: Placebo 1 to Probiotic A
42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)
Active Comparator: Placebo 2 to Probiotic B
Sequence B1 (n=25): Placebo 2 administered daily for 42 days, followed by 21 days washout and 42 days Probiotic formula: containing 1 x 10^9 CFU of Probiotic B administered daily
Dietary supplement: Placebo 2 to Probiotic B
42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)
Active Comparator: Probiotic A to Placebo 1
Sequence A2 (n=25): 1 x 10^9 CFU of Probiotic A administered daily for 42 days, followed by 21 days washout, then Placebo 1 administered daily for 42 days
Dietary supplement: Probiotic A to Placebo 1
42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)
Active Comparator: Probiotic B to Placebo 2
Sequence B2 (n=25): 1 x 10^9 CFU of Probiotic B administered daily for 42 days, followed by 21 days washout and 42 days Placebo 2 administered daily for 42 days
Dietary supplement: Probiotic B to Placebo 2
42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in GSRS-IBS score
Time Frame: Baseline vs Week 6
Change in the GSRS-IBS score while participants are on the treatment as compared with placebo. GSRS-IBS ranges from 0-78 with a greater score indicating a higher occurence of gastrointestinal symptoms
Baseline vs Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of upper respiratory tract symptoms
Time Frame: Baseline vs Week 6
Incidence of upper respiratory tract symptoms, as captured by incidence of upper respiratory tract as reported by clinician/PI
Baseline vs Week 6
Duration of upper respiratory tract symptoms
Time Frame: Baseline vs Week 6
Duration of upper respiratory tract symptoms, as captured by duration of upper respiratory tract as reported by clinician/PI
Baseline vs Week 6
Incidence of urinary tract infections
Time Frame: Baseline vs Week 6
Incidence of urinary tract infections, as captured by incidence of urinary tract infections as reported by clinician/PI
Baseline vs Week 6
Duration of urinary tract infections
Time Frame: Baseline vs Week 6
Duration of urinary tract infections, as captured by duration of urinary tract infections as reported by clinician/PI
Baseline vs Week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Stool consistency
Time Frame: Baseline vs Week 6
To evaluate the difference in stool consistency as determined by daily Bristol stool chart scale captured in daily diary. The Bristol stool chart ranges from 1-7, with 1,2 being hard and solid and 6,7 being loose and watery. This readout will be the change in stool consistency towards types 3,4 and 5
Baseline vs Week 6
Questionnaire regarding general health
Time Frame: Baseline vs Week 6
General health questionnaire regarding mood, sleep, energy, concentration and changes in appetite. This is based on a Likert scale ranging from 0 (no effect) to 7 (severe)
Baseline vs Week 6
Changes in microbiome readouts
Time Frame: Baseline vs Week 6
To determine if there are any changes in alpha and beta diversity in the microbiome using 16S rRNA sequencing ( a common methodology used in assessing microbiome readouts) between placebo and probiotic treatment.
Baseline vs Week 6
Changes in blood immune biomarkers
Time Frame: Baseline vs Week 6
To determine if there are any changes in biomarkers relating to immune markers including IL-6 (IL interleukin), IL-10, TNFalpha, IFNgamma in pg/mL serum.
Baseline vs Week 6
Regularity of defecation
Time Frame: Baseline vs Week 6
Regularity of defecation as captured by daily diary
Baseline vs Week 6
Changes in serum short chain fatty acid levels
Time Frame: Baseline vs Week 6
Changes in serum short chain fatty acids (SCFA's) including acetate, propionate and butyrate in micromol/L)
Baseline vs Week 6
Changes in serum amino acids levels
Time Frame: Baseline vs Week 6
Changes in serum amino acids levels including the essential amino acids histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine; and the non-essential amino acids alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine in micromol/L
Baseline vs Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Archer-Daniels-Midland Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merieux NutriSciences (China)

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCTB202108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings