Gastrointestinal DysfunctionCODECSNCT06466174
Determination of the Safety and Efficacy of Two Probiotic Strains
A study of Gastrointestinal Dysfunction, run by The Archer-Daniels-Midland Company.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed consent form
- Healthy adults aged 18-65 years
- Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
Who cannot join
- 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
- Severe chronic illnesses
- Known immunodeficiency
- Use of immunosuppressive agents (corticosteroids, methotrexate…)
- Presence of severe immunodeficient family members as provided by subjects self-report
- Pregnancy, 6 months postpartum period or current breastfeeding
Show all 10Show fewer
- Women of childbearing age planning pregnancy during the course of the study
- 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
- Not able to understand and comply with requirements of the study
- Use of probiotics, prebiotics, postbiotics, antibiotics within 3 weeks of study commencement
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Placebo 1 to Probiotic A, Probiotic A to Placebo 1, Placebo 2 to Probiotic B, Probiotic B to Placebo 2
- Keywords
- probiotic, gastrointestinal discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 1 to Probiotic ADietary supplement
42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)
Probiotic A to Placebo 1Dietary supplement
42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)
Placebo 2 to Probiotic BDietary supplement
42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)
Probiotic B to Placebo 2Dietary supplement
42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)
| Study group | Role | What they receive |
|---|---|---|
| Placebo 1 to Probiotic A | Active comparator | 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 Receives: Dietary Supplement: Placebo 1 to Probiotic A |
| Placebo 2 to Probiotic B | Active comparator | 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 Receives: Dietary Supplement: Placebo 2 to Probiotic B |
| Probiotic A to Placebo 1 | Active comparator | 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 Receives: Dietary Supplement: Probiotic A to Placebo 1 |
| Probiotic B to Placebo 2 | Active comparator | 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 Receives: Dietary Supplement: Probiotic B to Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GSRS-IBS score
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
Measured: Baseline vs Week 6
Secondary outcomes (4)
Incidence of upper respiratory tract symptoms
Incidence of upper respiratory tract symptoms, as captured by incidence of upper respiratory tract as reported by clinician/PI
Measured: Baseline vs Week 6
Duration of upper respiratory tract symptoms
Duration of upper respiratory tract symptoms, as captured by duration of upper respiratory tract as reported by clinician/PI
Measured: Baseline vs Week 6
Incidence of urinary tract infections
Incidence of urinary tract infections, as captured by incidence of urinary tract infections as reported by clinician/PI
Measured: Baseline vs Week 6
Duration of urinary tract infections
Duration of urinary tract infections, as captured by duration of urinary tract infections as reported by clinician/PI
Measured: Baseline vs Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo crossover to probiotic A Probiotic A crossover to Placebo Placebo crossover to probiotic B Probiotic B crossover to Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466174
- Sponsor's protocol ID
- PCTB202108
- Acronym
- CODECS
- Status last verified
- Jun 2024
- First submitted
- 16 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Safety and Efficacy of Two Probiotic Strains in Adults With Mild to Moderate Gastrointestinal Discomfort
- ClinicalTrials.gov ID
- NCT06466174
- Acronym / sponsor ID
- CODECS / PCTB202108
- Conditions
- Gastrointestinal Dysfunction
- Keywords
- probiotic, gastrointestinal discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China)
- Study start
- Jun 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Placebo crossover to probiotic A Probiotic A crossover to Placebo Placebo crossover to probiotic B Probiotic B crossover to Placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo 1 to Probiotic A | Active comparator | Dietary Supplement: Placebo 1 to Probiotic ASequence 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 |
| Placebo 2 to Probiotic B | Active comparator | Dietary Supplement: Placebo 2 to Probiotic BSequence 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 |
| Probiotic A to Placebo 1 | Active comparator | Dietary Supplement: Probiotic A to Placebo 1Sequence 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 |
| Probiotic B to Placebo 2 | Active comparator | Dietary Supplement: Probiotic B to Placebo 2Sequence 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed consent form
- Healthy adults aged 18-65 years
- Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
Key exclusion criteria (10 listed)
- 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
- Severe chronic illnesses
- Known immunodeficiency
- Use of immunosuppressive agents (corticosteroids, methotrexate…)
- Presence of severe immunodeficient family members as provided by subjects self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo 1 to Probiotic A42 day Crossover study design between Placebo 1 and Probiotic A (n = 25) | Dietary supplement | Placebo 1 to Probiotic A |
| Probiotic A to Placebo 142 day Crossover study design between Probiotic A and Placebo 1 (n = 25) | Dietary supplement | Probiotic A to Placebo 1 |
| Placebo 2 to Probiotic B42 day Crossover study design between Placebo 2 and Probiotic B (n = 25) | Dietary supplement | Placebo 2 to Probiotic B |
| Probiotic B to Placebo 242 day Crossover study design between Probiotic B and Placebo 2 (n = 25) | Dietary supplement | Probiotic B to Placebo 2 |
Primary outcome
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
4 secondary outcomes
Incidence of upper respiratory tract symptoms
Time frame: Baseline vs Week 6
Duration of upper respiratory tract symptoms
Time frame: Baseline vs Week 6
Incidence of urinary tract infections
Time frame: Baseline vs Week 6
Duration of urinary tract infections
Time frame: Baseline vs Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Gastrointestinal Dysfunction, run by The Archer-Daniels-Midland Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GSRS-IBS score (time frame: Baseline vs Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.