Changes in Gut Microbiota with Prebiotic SupplementationNCT06611215
Effect of a Nutritional Supplement on Gut Microbiota in Adults
A study testing Treatment in people with Changes in Gut Microbiota with Prebiotic Supplementation and Quality of Life, run by Pharmavite LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Gut Microbiota with Prebiotic Supplementation, Quality of Life
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 2 Jun 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
- 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.
- 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.
Show all 24Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Clinical Trials, 142 E Ontario St
Chicago, Illinois, 60611
Kevin O'Regan, Operations Manager, 312-535-9440, koregan@atlantiatrials.com
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life.
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.
Read the detailed description
This is a 4 arm randomized, placebo-controlled, double-blind, parallel study, which will be conducted remotely and will include 4 visits over 10 week period - a screening visit (Visit 1; week -2), a 2-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and two test visits (Visits 3 and 4 at days 28, and 56 respectively).
SCREENING Visit 1 - Week -2
At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:
- Participants will receive oral and written information about the study and be allowed to ask questions.
- Participants will sign the informed consent document.
- Inclusion and exclusion criteria will be reviewed.
- Demographic, health, and lifestyle data will be collected.
- Medical history will be collected.
- Concomitant medication will be recorded.
- Height and weight will be collected , Body Mass Index (BMI) calculated.
- Complete Block Fiber screener
Participants will be given an appointment to return to the study site within 14 days for their baseline/day 1 visit.
INTERVENTION PHASE Visit 2 - Week 0
Participants will attend this study visit and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Inclusion/exclusion criteria will be reviewed.
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Weight will be measured, and BMI calculated.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
Participants will be randomized into one of two treatment groups as follows, but will be blinded as to which group, they are in:
- Group 1: Prebiotic 1
- Group 2: Placebo 1
- Group 3: Prebiotic 2
- Group 4: Placebo 2
Participants will be supplied with an 8-week supply of study product and instructions of dosing. Participants will be instructed to take one stick pack each day for the next eight weeks. An additional eight four days of doses will be supplied in case of delay of study visit or loss of study product.
- Participants will be provided with an appointment to return to the study site in four weeks.
Visit 3 - Week 4
Participants will return for virtual visit:
- Participant's continued consent to study procedures will be confirmed.
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Weight will be measured, and BMI calculated.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- - Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
- Participants will be provided with an appointment to return to the study site in four weeks.
Visit 4 (Final Visit) - Week 8
Participants will return to the study site at day 56 and the following procedures will be carried out:
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Participants will return any unused study product and compliance will be assessed.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- Participants will return their 3-day food diary.
- Weight will be measured, and BMI calculated.
- Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
- Being tested
- Treatment, Placebo
- Keywords
- microbiome, dietary supplement, prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDietary supplement
Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning
PlaceboDietary supplement
Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning
TreatmentDietary supplement
Prebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning
PlaceboDietary supplement
Placebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic 1 | Experimental | Not described Receives: Dietary Supplement: Treatment |
| Placebo 1 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Prebiotic 2 | Experimental | Not described Receives: Dietary Supplement: Treatment |
| Placebo 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo
Measured: From baseline to Week 8
Secondary outcomes (3)
To evaluate the effect of consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at Week 4
Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 28) in the two prebiotic supplements compared to the corresponding Placebo
Measured: From baseline to week 4
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 4
Change in Quality-of-Life scores (measured by 36-Item Short Form Health Survey (SF-36 RAND)) from baseline to end of intervention (Day 28) in the two prebiotic supplements compared to the corresponding Placebo in healthy adult population. The 36-Item Short Form Health Survey is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions . These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase
Measured: From baseline to week 4
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 8
Change in Quality-of-Life scores (measured by 36-Item Short Form Health Survey (SF-36 RAND)) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo in healthy adult population. The 36-Item Short Form Health Survey is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions . These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase
Measured: From baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start23 Sep 2024 (estimated)
- Primary completion7 Apr 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Changes in Gut Microbiota with Prebiotic SupplementationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 4 arm double blind randomized placebo controlled trial for 2 prebiotic supplements with respective placebos as parallel groups - 2 treatments and 2 placebos.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmavite LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611215
- Sponsor's protocol ID
- AFCRO-184
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
PubMed 28611480
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life.
- ClinicalTrials.gov ID
- NCT06611215
- Acronym / sponsor ID
- AFCRO-184
- Keywords
- microbiome, dietary supplement, prebiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pharmavite LLCIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 23 Sep 2024 (estimated)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 24 Sep 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.
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.
Detailed description
This is a 4 arm randomized, placebo-controlled, double-blind, parallel study, which will be conducted remotely and will include 4 visits over 10 week period - a screening visit (Visit 1; week -2), a 2-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and two test visits (Visits 3 and 4 at days 28, and 56 respectively).
SCREENING Visit 1 - Week -2
At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:
- Participants will receive oral and written information about the study and be allowed to ask questions.
- Participants will sign the informed consent document.
- Inclusion and exclusion criteria will be reviewed.
- Demographic, health, and lifestyle data will be collected.
- Medical history will be collected.
- Concomitant medication will be recorded.
- Height and weight will be collected , Body Mass Index (BMI) calculated.
- Complete Block Fiber screener
Participants will be given an appointment to return to the study site within 14 days for their baseline/day 1 visit.
INTERVENTION PHASE Visit 2 - Week 0
Participants will attend this study visit and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Inclusion/exclusion criteria will be reviewed.
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Weight will be measured, and BMI calculated.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
Participants will be randomized into one of two treatment groups as follows, but will be blinded as to which group, they are in:
- Group 1: Prebiotic 1
- Group 2: Placebo 1
- Group 3: Prebiotic 2
- Group 4: Placebo 2
Participants will be supplied with an 8-week supply of study product and instructions of dosing. Participants will be instructed to take one stick pack each day for the next eight weeks. An additional eight four days of doses will be supplied in case of delay of study visit or loss of study product.
- Participants will be provided with an appointment to return to the study site in four weeks.
Visit 3 - Week 4
Participants will return for virtual visit:
- Participant's continued consent to study procedures will be confirmed.
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Weight will be measured, and BMI calculated.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- - Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
- Participants will be provided with an appointment to return to the study site in four weeks.
Visit 4 (Final Visit) - Week 8
Participants will return to the study site at day 56 and the following procedures will be carried out:
- Adverse events will be recorded.
- Concomitant medication/supplements will be recorded.
- Participants will return any unused study product and compliance will be assessed.
- Participants will return their saliva samples and samples will be stored for future analysis.
- Participants will return their stool sample and sample will be stored for future analysis.
- Participants will return their 3-day food diary.
- Weight will be measured, and BMI calculated.
- Participants will have completed the following questionnaires within 24 hours of the visit:
- 36 item short form survey (SF-36)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a 4 arm double blind randomized placebo controlled trial for 2 prebiotic supplements with respective placebos as parallel groups - 2 treatments and 2 placebos.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic 1 | Experimental | Dietary Supplement: Treatment |
| Placebo 1 | Placebo comparator | Dietary Supplement: Placebo |
| Prebiotic 2 | Experimental | Dietary Supplement: Treatment |
| Placebo 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
- 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.
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 |
|---|---|---|
| TreatmentPrebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning | Dietary supplement | Prebiotic 1 |
| PlaceboPlacebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning | Dietary supplement | Placebo 1 |
| TreatmentPrebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning | Dietary supplement | Prebiotic 2 |
| PlaceboPlacebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning | Dietary supplement | Placebo 2 |
Primary outcome
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
Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo
3 secondary outcomes
To evaluate the effect of consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at Week 4
Time frame: From baseline to week 4
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 4
Time frame: From baseline to week 4
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 8
Time frame: From baseline to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 28611480Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Changes in Gut Microbiota with Prebiotic Supplementation
Not yet recruiting
Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota in Older Adults with or At Risk of Disease Related Malnutrition
Changes in Gut Microbiota Bifidobacterial Levels
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Changes in Gut Microbiota with Prebiotic Supplementation and Quality of Life, run by Pharmavite LLC at 1 site in United States.
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 8 inclusion and 24 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Kevin O'Regan, Operations Manager (312-535-9440, koregan@atlantiatrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611215, which also lists 1 linked publication.
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 24 Sep 2024.