Microbial ColonizationFEEDMeNCT06395324
Fiber Effectively Educates & Directs the Microbiome Study
A study testing High arabinose diet in people with Microbial Colonization, run by University of California, Davis at 1 site in United States.
Trial summary
The FEEDMe Study is a single-group, open label pilot study exploring how diverse, commercially available foods rich in arabinose influence the gut microbiome in adults from diverse populations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- High arabinose diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2024to 9 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults;
- Age 18-50 years of age;
- BMI between 18.5 and 34.9 kg/m2;
- Lives within a 40-mile radius from the UC Davis campus in Davis or UCDMC in - Sacramento, CA or study personnel residences;
- Consumes food at least three times (meals/snacks) per day;
- Non-alcohol consumers or those who consume alcohol in moderation defined as having up to 1 drink per day for women and up to 2 drinks per day for men;
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- Normal stool frequency defined as 3 times per week to 3 times per day;
- Has been weight-stable (has not lost or gained 10% of body weight) within the past 3 months;
- Speaks, writes, and understands English to complete study activities;
- Lives in a household whereby stool samples and study food can be reliably stored without interference from other household members (i.e., excluding individuals who reside in fraternity, sorority houses whereby freezer access is open to all members);
- Lives in a household with access to Wi-Fi and/or cellular access to enable completion of electronic questionnaires (i.e., PIP forms) on their own personal computer, cell phone, or electronic device;
- Willingness to consume study-provided foods for 18 consecutive days;
- Willingness to fill out a short online survey about the amount of each study food they consumed during the two-week intervention;
- Willingness to collect stool samples on three separate days and store them in their home freezer before they (or study personnel) transport them to UC Davis;
- Willingness to complete online weekly health questionnaires;
- Willingness to complete two online enrollment questionnaires about diet and health history;
- Willingness to complete Daily Stool Logs (7 consecutive days) at 3 separate times during the study period;
- Willingness to complete two 24-hour dietary recalls by video call with study personnel (prior to each of the 3 stool collections required for the study);
- Willingness to have four in-person visits (at their homes or on campus);
- Willingness to use their personal computer, cell phone, or electronic device to meet virtually with study personnel;
- Willingness to refrain from consuming fermented foods, or foods with probiotics or probiotic supplements and other foods listed on the study materials (confounding variables of the intestinal microbiome) during the study period;
- Willingness to refrain from consuming iron containing dietary supplements (multi-vitamin is permitted) and fiber supplements during the study period;
- Willingness to refrain from changing (starting a new or discontinuing a current) routine vitamin/mineral supplement regimen during the study period;
- Willingness to refrain from changing (starting a new or discontinuing a current) routine medication regimen during the study period;
- Willingness to refrain from consuming laxatives during the study period;
- Willingness to refrain from enrolling in other experimental trials during the study period;
- Willingness to avoid binge alcohol drinking during the study period defined by the CDC as: drinking 5 or more drinks on a single occasion for men or 4 or more drinks on a single occasion for women, generally within about 2 hours;
- Willingness to refrain from using tobacco (smoking or chewing or using E-cigarettes) or smoking, vaping or consuming cannabis or use of other illicit drugs during the study period;
- Willingness to refrain from having any non-emergency, elective surgeries including dental surgery or invasive medical procedures during the study period;
- Willingness to take a study-provided urine pregnancy test if female;
- Mid- to high-income families and low-income families based on household income or eligibility for the California Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Who cannot join
- Currently pregnant or plans to become pregnant several weeks prior to enrollment and during the study period;
- Currently lactating;
- Use of restrictive diets such as caloric restriction, intermittent fasting, keto-diet, gluten-free, grain-free, dairy-free within the past 6 months;
- Known or suspected allergy (childhood allergies pre-puberty is acceptable) to milk, egg, wheat, legumes including soybeans; peanuts, tree nuts and seeds, and any fruits and vegetables used in the study;
- Known or suspected sensitivity or intolerances to any foods and ingredients used in the study (e.g., lactose intolerance, etc.) such as milk, egg, wheat, legumes including soybeans, peanuts, tree nuts and seeds and any fruits and vegetables used in the study;
- Aversions to or avoidance in eating foods and ingredients used in the study (legumes/beans, fruits, vegetables, peanuts, tree nuts and seeds);
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- History of any type of eating disorder (anorexia nervosa, bulimia, etc.);
- History of any of the following: Positive infection of HIV, AIDS, hepatitis B or C; GI tract abnormalities; Any type of bariatric surgery or other gastric surgery involving the removal of sections of the GI tract (appendectomy or hernia repairs are acceptable), or gall-bladder removal; GI-related conditions such as malabsorption disease, celiac disease, Crohn's disease, colitis, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS); Cancer (history of skin cancer that is in remission is acceptable), heart, liver, lung, endocrine, or kidney diseases; Type 1 or 2 diabetes mellitus; Cushing syndrome; Primary immune deficiency or autoimmune diseases; Uncontrolled hyper or hypothyroidism; uncontrolled hypertension (controlled with medication is acceptable);
- History of stomach ulcers or diagnosis with H. pylori infection; chronic gastritis within the past 12 months;
- Gastroenteritis (caused by stomach flu or food poisoning caused by virus or bacteria) within the past 4 weeks;
- Have any medical or nutritional conditions that require iron supplementation;
- Intake of iron supplements (stand-alone doses that are not part of a multi-vitamin) within the past 4 weeks;
- Positive test for COVID-19 based on a rapid test or PCR within the past 2 weeks;
- Use of oral, intramuscular or IV antibiotics or sulfonamides within the past 3 months;
- Vaccinations received less than the past 2 weeks (may enroll two weeks following treatment with vaccinations);
- Use of biologics that suppress the immune system, i.e., Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel, for 2 weeks or longer or within the past 4 weeks;
- Use of injectable (or pill) weight loss medications or biologics such as Ozempic, Wegovy, Rybelsus, etc. within the past 4 weeks;
- Surgery or an invasive medical procedure within the past 3 months;
- Plan to have any elective surgeries including dental surgery or invasive medical procedures during the study period;
- Illness (flu, cold, etc.) within the past 2 weeks (free of all illness symptoms within the past 2 weeks);
- Routine use of medications found to alter the gut microbiome such as: Tylenol, aspirin, naproxen sodium or ibuprofen (except for acute uses with sickness or injury), anticholinergic inhalers, opioids, proton pump inhibitors, gastric acid suppressors (e.g., pepcid), metformin, statins, steroids (oral-inhaler is acceptable), 6-Marcaptopurine, Azathioprine or any other immunosuppressants on a daily basis within the past 6 months;
- Plans to start or plans to have changes made to a dose (including starting or adjusting an existing dose) of selective serotonin reuptake inhibitors (SSRIs), or antipsychotics during the study period;
- Plans to start or plans to have changes made to a dietary supplement regimen (vitamins/minerals/herbal supplements) or a medication regimen during the study period;
- Persistent (lasts longer than 2 weeks and less than 4 weeks) or chronic (lasts at least 4 weeks) diarrhea (loose, watery stools three or more times a day) within the past 6 months;
- Chronic constipation (fewer than 3 stools per week, stool form that is mostly hard or lumpy and difficult stool passage (need to strain or incomplete evacuation) with the past 3 months;
- Use of probiotic supplements within the past 8 weeks;
- Individuals who use laxatives more than once per week;
- Individuals who use fiber supplements more than once per week;
- Current tobacco (smoking or chewing) or E-cigarette users or individuals who quit using less than one year before enrolling in the study;
- Frequent cannabis use (eating, smoking, or vaping) defined as greater than 4 times per week and greater than 14 times per month;
- Use of illicit drugs (cocaine, crack, heroine, unprescribed fentanyl etc.);
- Excessive alcohol drinkers: For men, heavy drinking is typically defined as consuming 15 drinks or more per week. For women, heavy drinking is typically defined as consuming 8 drinks or more per week (https://www.cdc.gov/alcohol/faqs.htm);
- Individuals who currently live or plan to live within the same household during the study period or who are in intimate relationships with current or past study participants (to avoid horizontal transfer of the gut microbiome),
- Individuals who plan to travel during the stool collections and intervention phase of the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
The FEEDMe Study is a single-group, open label pilot study exploring how diverse, commercially available foods rich in arabinose influence the gut microbiome in adults from diverse populations.
Read the detailed description
Upon enrollment, healthy adults will enter a 15-day lead-in period during which they will refrain from consuming specific foods and collect a baseline stool sample. The intervention period will be on days 16-33 during which participants will consume study provided high-arabinose foods. The follow-up period will be on days 34-49 during which participants will no longer eat the study foods and will refrain from consuming specific foods. The total duration of the study will be approximately 7 weeks. Stool samples will be collected on 3 occasions and participants will be asked to complete questionnaires, daily stool logs, dietary intake reports, and 24-hour dietary recalls throughout the course of the study.
- Conditions
- Microbial Colonization
- Being tested
- High arabinose diet
- Keywords
- Fecal microbiome, Arabinose, Fecal glycome, Fecal short chain fatty acids, Fiber, High arabinose diet
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High arabinose dietOther
Participants will consume a high arabinose diet for 18 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Pre, during and post high arabinose foods intake | Experimental | All individuals will enter a lead-in period consisting of a low arabinose diet, then they will consume a high arabinose diet and then back to the low arabinose diet. Receives: Other: High arabinose diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiome
Examine changes to the concentration and distribution of fecal microbiota in response to consuming a high arabinose diet as measured by 16s rRNA sequencing and metagenomics.
Measured: Change from baseline to days 31 and 47
Fecal glycome
Determine changes in fecal glycome in response to consumption of a high arabinose diet as measured by metagenomic analysis and mass spectrometry.
Measured: Change from baseline to days 31 and 47
Fecal SCFAs
Determine changes in fecal SCFAs in response to consumption of a high arabinose diet as measured by mass spectrometry.
Measured: Change from baseline to days 31 and 47
Gastrointestinal tolerance
Assess gastrointestinal tolerance to a high arabinose diet as measured by questionnaires that ask participants to report gastrointestinal symptoms. A list of GI symptoms are listed in the weekly survey and participants will select none, mild, moderate, severe or unsure. The proportion of severe responses will be compared across the study weeks.
Measured: Change from baseline to days 31 and 47
Stool consistency and frequency
Determine changes in fecal consistency and frequency in response to a high arabinose diet as measured by questionnaires that ask participants to report their number of stools per day and to rank the consistency of their stools using the Bristol Stool Scale. For seven days prior to each of the three stool collections, participants will rate their stool consistency on a scale from 1-7 and these values will be averaged and compared across the three time points (pre, during and post high arabinose diet). This scale is not continuous but rather nominal and the proportion of 4 and 5 is considered "normal" stoo consistency.
Measured: Change from baseline to days 16-33
Study food acceptability
Examine overall acceptability and sensory perceptions of high arabinose commercially available products as measured by questionnaires. Participants will rate how much they like each study food after consuming each one for the first time on a continuous scale from 0 to 100 where 0 equals did not like at all and 100 equals extremely liked. The scores will be reported for each food.
Measured: Intervention period: days 31-46
Study expansion feasibility
Evaluate the overall satisfaction of participants' experience for feedback on the study protocol and study duration. At the end of the study, participants will rate their satisfaction on a continuous scale from 0 to 100, where 0 equals not satisfied at all and 100 equals extremely satisfied.
Measured: Study period: Days 1-49
Follow-up period evaluation
Evaluate if 14 days of avoiding arabinose foods is a sufficient washout period to result in changes in concentration and distribution of gut microbiota as measured by 16s rRNA sequencing and metagenomics.
Measured: Follow-up period: days 34-49
Secondary outcomes (2)
Fecal immune markers
Determine changes in fecal immune and inflammatory markers such as levels of immunoglobulins in response to a high arabinose diet as measured by ELISA and mass spectrometry.
Measured: Change from baseline to days 31 and 47
Fecal metabolomics
Determine changes in fecal metabolites and organic acids in response to a high arabinose diet as measured by mass spectrometry.
Measured: Change from baseline to days 31 and 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start21 Aug 2024
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be enrolled and will consume study provided high arabinose foods during the intervention period.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Smilowitz, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395324
- Sponsor's protocol ID
- 2117625
- Acronym
- FEEDMe
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041.
PubMed 29757343Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18.
PubMed 33208922U.S. Department of Agriculture USDoHaHS. Dietary Guidelines for Americans, 2020-2025. 2020(9th Edition).
Castillo JJ, Couture G, Bacalzo NP Jr, Chen Y, Chin EL, Blecksmith SE, Bouzid YY, Vainberg Y, Masarweh C, Zhou Q, Smilowitz JT, German JB, Mills DA, Lemay DG, Lebrilla CB. The Development of the Davis Food Glycopedia-A Glycan Encyclopedia of Food. Nutrients. 2022 Apr 14;14(8):1639. doi: 10.3390/nu14081639.
PubMed 35458202Delannoy-Bruno O, Desai C, Raman AS, Chen RY, Hibberd MC, Cheng J, Han N, Castillo JJ, Couture G, Lebrilla CB, Barve RA, Lombard V, Henrissat B, Leyn SA, Rodionov DA, Osterman AL, Hayashi DK, Meynier A, Vinoy S, Kirbach K, Wilmot T, Heath AC, Klein S, Barratt MJ, Gordon JI. Evaluating microbiome-directed fibre snacks in gnotobiotic mice and humans. Nature. 2021 Jul;595(7865):91-95. doi: 10.1038/s41586-021-03671-4. Epub 2021 Jun 23.
PubMed 34163075
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber Effectively Educates & Directs the Microbiome Study
- ClinicalTrials.gov ID
- NCT06395324
- Acronym / sponsor ID
- FEEDMe / 2117625
- Conditions
- Microbial Colonization
- Keywords
- Fecal microbiome, Arabinose, Fecal glycome, Fecal short chain fatty acids, Fiber, High arabinose diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 2 May 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 FEEDMe Study is a single-group, open label pilot study exploring how diverse, commercially available foods rich in arabinose influence the gut microbiome in adults from diverse populations.
Detailed description
Upon enrollment, healthy adults will enter a 15-day lead-in period during which they will refrain from consuming specific foods and collect a baseline stool sample. The intervention period will be on days 16-33 during which participants will consume study provided high-arabinose foods. The follow-up period will be on days 34-49 during which participants will no longer eat the study foods and will refrain from consuming specific foods. The total duration of the study will be approximately 7 weeks. Stool samples will be collected on 3 occasions and participants will be asked to complete questionnaires, daily stool logs, dietary intake reports, and 24-hour dietary recalls throughout the course of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be enrolled and will consume study provided high arabinose foods during the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Pre, during and post high arabinose foods intake | Experimental | Other: High arabinose dietAll individuals will enter a lead-in period consisting of a low arabinose diet, then they will consume a high arabinose diet and then back to the low arabinose diet. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (31 listed)
- Healthy adults;
- Age 18-50 years of age;
- BMI between 18.5 and 34.9 kg/m2;
- Lives within a 40-mile radius from the UC Davis campus in Davis or UCDMC in - Sacramento, CA or study personnel residences;
- Consumes food at least three times (meals/snacks) per day;
Key exclusion criteria (34 listed)
- Currently pregnant or plans to become pregnant several weeks prior to enrollment and during the study period;
- Currently lactating;
- Use of restrictive diets such as caloric restriction, intermittent fasting, keto-diet, gluten-free, grain-free, dairy-free within the past 6 months;
- Known or suspected allergy (childhood allergies pre-puberty is acceptable) to milk, egg, wheat, legumes including soybeans; peanuts, tree nuts and seeds, and any fruits and vegetables used in the study;
- Known or suspected sensitivity or intolerances to any foods and ingredients used in the study (e.g., lactose intolerance, etc.) such as milk, egg, wheat, legumes including soybeans, peanuts, tree nuts and seeds and any fruits and vegetables used in the study;
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 |
|---|---|---|
| High arabinose dietParticipants will consume a high arabinose diet for 18 consecutive days. | Other | Pre, during and post high arabinose foods intake |
Primary outcome
Fecal microbiome
Time frame: Change from baseline to days 31 and 47
Examine changes to the concentration and distribution of fecal microbiota in response to consuming a high arabinose diet as measured by 16s rRNA sequencing and metagenomics.
Fecal glycome
Time frame: Change from baseline to days 31 and 47
Determine changes in fecal glycome in response to consumption of a high arabinose diet as measured by metagenomic analysis and mass spectrometry.
Fecal SCFAs
Time frame: Change from baseline to days 31 and 47
Determine changes in fecal SCFAs in response to consumption of a high arabinose diet as measured by mass spectrometry.
Gastrointestinal tolerance
Time frame: Change from baseline to days 31 and 47
Assess gastrointestinal tolerance to a high arabinose diet as measured by questionnaires that ask participants to report gastrointestinal symptoms. A list of GI symptoms are listed in the weekly survey and participants will select none, mild, moderate, severe or unsure. The proportion of severe responses will be compared across the study weeks.
Stool consistency and frequency
Time frame: Change from baseline to days 16-33
Determine changes in fecal consistency and frequency in response to a high arabinose diet as measured by questionnaires that ask participants to report their number of stools per day and to rank the consistency of their stools using the Bristol Stool Scale. For seven days prior to each of the three stool collections, participants will rate their stool consistency on a scale from 1-7 and these values will be averaged and compared across the three time points (pre, during and post high arabinose diet). This scale is not continuous but rather nominal and the proportion of 4 and 5 is considered "normal" stoo consistency.
Study food acceptability
Time frame: Intervention period: days 31-46
Examine overall acceptability and sensory perceptions of high arabinose commercially available products as measured by questionnaires. Participants will rate how much they like each study food after consuming each one for the first time on a continuous scale from 0 to 100 where 0 equals did not like at all and 100 equals extremely liked. The scores will be reported for each food.
Study expansion feasibility
Time frame: Study period: Days 1-49
Evaluate the overall satisfaction of participants' experience for feedback on the study protocol and study duration. At the end of the study, participants will rate their satisfaction on a continuous scale from 0 to 100, where 0 equals not satisfied at all and 100 equals extremely satisfied.
Follow-up period evaluation
Time frame: Follow-up period: days 34-49
Evaluate if 14 days of avoiding arabinose foods is a sufficient washout period to result in changes in concentration and distribution of gut microbiota as measured by 16s rRNA sequencing and metagenomics.
2 secondary outcomes
Fecal immune markers
Time frame: Change from baseline to days 31 and 47
Fecal metabolomics
Time frame: Change from baseline to days 31 and 47
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 27 Aug 2025.
- Background: PubMed 29757343So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041.
- Background: PubMed 33208922Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18.
- BackgroundU.S. Department of Agriculture USDoHaHS. Dietary Guidelines for Americans, 2020-2025. 2020(9th Edition).
- Background: PubMed 35458202Castillo JJ, Couture G, Bacalzo NP Jr, Chen Y, Chin EL, Blecksmith SE, Bouzid YY, Vainberg Y, Masarweh C, Zhou Q, Smilowitz JT, German JB, Mills DA, Lemay DG, Lebrilla CB. The Development of the Davis Food Glycopedia-A Glycan Encyclopedia of Food. Nutrients. 2022 Apr 14;14(8):1639. doi: 10.3390/nu14081639.
- Background: PubMed 34163075Delannoy-Bruno O, Desai C, Raman AS, Chen RY, Hibberd MC, Cheng J, Han N, Castillo JJ, Couture G, Lebrilla CB, Barve RA, Lombard V, Henrissat B, Leyn SA, Rodionov DA, Osterman AL, Hayashi DK, Meynier A, Vinoy S, Kirbach K, Wilmot T, Heath AC, Klein S, Barratt MJ, Gordon JI. Evaluating microbiome-directed fibre snacks in gnotobiotic mice and humans. Nature. 2021 Jul;595(7865):91-95. doi: 10.1038/s41586-021-03671-4. Epub 2021 Jun 23.
- 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.
Jennifer Smilowitz, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High arabinose diet in people with Microbial Colonization, run by University of California, Davis 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 31 inclusion and 34 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 27 Aug 2025. 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?
Fecal microbiome (time frame: Change from baseline to days 31 and 47). The study lists 8 primary outcomes in all. 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 NCT06395324, which also lists 5 linked publications.
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 27 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.