Healthy Gut MicrobiotaNCT03595306
Human Gut Microbiota and Prebiotic Response
A study testing Prebiotic A - inulin, Prebiotic B - galactooligosaccharides(GOS) and Prebiotic C - wheat dextrin in people with Healthy Gut Microbiota, run by Duke University at 1 site in United States.
Trial summary
This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Gut Microbiota
- What is being tested?
- Prebiotic A - inulin, Prebiotic B - galactooligosaccharides(GOS) and Prebiotic C - wheat dextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 19 May 2019
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provide Stool Samples at no risk to yourself
Who cannot join
- No oral antibiotic treatments within previous 1 month
- No known allergy to milk products or lactose intolerance
- no known allergy to wheat or gluten intolerance
- no history of irritable bowel syndrome
- no history of inflammatory bowel disease
- no history of type-2 diabetes
Show all 10Show fewer
- no history of chronic kidney disease or reduced kidney function
- no current intestinal obstructions
- no current untreated colorectal cancer
- not currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.
- Conditions
- Healthy Gut Microbiota
- Being tested
- Prebiotic A - inulin, Prebiotic B - galactooligosaccharides(GOS), Prebiotic C - wheat dextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic A - inulinDietary supplement
Pre-weighed packages will be given twice daily for 5 days.
Prebiotic B - galactooligosaccharides(GOS)Dietary supplement
Pre-weighed packages will be given twice daily for 5 days.
Prebiotic C - wheat dextrinDietary supplement
Pre-weighed packages will be given twice daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic A | Experimental | Not described Receives: Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic C - wheat dextrin |
| Prebiotic B | Experimental | Not described Receives: Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic C - wheat dextrin |
| Prebiotic C | Experimental | Not described Receives: Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic C - wheat dextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in levels of SCFAs in stool samples
Measured: Baseline and 6 weeks
Secondary outcomes (1)
change in levels of cytokines in stool samples
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 May 2018
- Primary completion19 May 2019
- Study completion19 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence David, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595306
- Sponsor's protocol ID
- Pro00087214
- Status last verified
- May 2019
- First submitted
- 11 Jul 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Gut Microbiota and Prebiotic Response
- ClinicalTrials.gov ID
- NCT03595306
- Acronym / sponsor ID
- Pro00087214
- Conditions
- Healthy Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 May 2019 (actual)
- First posted
- 23 Jul 2018 (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.
This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prebiotic A | Experimental | Dietary Supplement: Prebiotic A - inulin, Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS), Dietary Supplement: Prebiotic C - wheat dextrin |
| Prebiotic B | Experimental | Dietary Supplement: Prebiotic A - inulin, Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS), Dietary Supplement: Prebiotic C - wheat dextrin |
| Prebiotic C | Experimental | Dietary Supplement: Prebiotic A - inulin, Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS), Dietary Supplement: Prebiotic C - wheat dextrin |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Provide Stool Samples at no risk to yourself
Key exclusion criteria (10 listed)
- No oral antibiotic treatments within previous 1 month
- No known allergy to milk products or lactose intolerance
- no known allergy to wheat or gluten intolerance
- no history of irritable bowel syndrome
- no history of inflammatory bowel disease
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 |
|---|---|---|
| Prebiotic A - inulinPre-weighed packages will be given twice daily for 5 days. | Dietary supplement | Prebiotic A, Prebiotic B, Prebiotic C |
| Prebiotic B - galactooligosaccharides(GOS)Pre-weighed packages will be given twice daily for 5 days. | Dietary supplement | Prebiotic A, Prebiotic B, Prebiotic C |
| Prebiotic C - wheat dextrinPre-weighed packages will be given twice daily for 5 days. | Dietary supplement | Prebiotic A, Prebiotic B, Prebiotic C |
Primary outcome
change in levels of SCFAs in stool samples
Time frame: Baseline and 6 weeks
1 secondary outcome
change in levels of cytokines in stool samples
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
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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.
Lawrence David principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic A - inulin, Prebiotic B - galactooligosaccharides(GOS) and Prebiotic C - wheat dextrin in people with Healthy Gut Microbiota, run by Duke University 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 1 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: finished, as of the sponsor's last update on 3 Jun 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 levels of SCFAs in stool samples (time frame: Baseline and 6 weeks). 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 3 Jun 2019; AzTrials last refreshed its copy on 2 Nov 2026.