PrebioticsPhase 4NCT07788924
Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule
A Phase 4 study testing FiberSmart in people with Prebiotics and Metagenomic Next Generation Sequencing, run by Anderson Advanced Ingredients at 1 site in Canada.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prebiotics, Metagenomic Next Generation Sequencing, Microbiome
- What is being tested?
- FiberSmart
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 19-40 years old at the inclusion of the study, both female and male subjects.
- Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.
- Willing to maintain their current lifestyle during the study.
- Able to swallow a 25mm length and 9mm width sized capsule.
- At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study.- Page 3 of 5 [DRAFT]
- Signed Informed Consent, and willing to follow the study procedures, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study.
Who cannot join
- Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).
- Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.
- Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.
- Less than 3 bowel movements a week
- If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after
- Prior gastrointestinal surgery, or radiation treatment which, in the Investigator's opinion, may lead to intestinal stricturing or obstruction with a risk of capsule non-excretion, including, e.g., untreated achalasia, eosinophilic esophagitis, cancer diagnosis (depending on timing, location, and treatment) or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
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- History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction.
- Organic motility disorder (e.g., gastroparesis, intestinal pseudo#obstruction, systemic sclerosis, Ogilvie's syndrome) with a history of swallowing difficulty or oropharyngeal dysphagia.
- Use of metformin within 3 months prior to the start of the study
- Use of any oral or intravenous antibiotics within 3 months prior to the baseline study timepoint (topical antibiotics are acceptable).
- Use of probiotics, prebiotics, fibre (Metamucil, FibreOne, etc.) or any other supplements known to affect the gastrointestinal microbiota within 14 days prior to the baseline study timepoint.
- Known or suspected allergy or intolerance to the IP or its components.
- Pregnant or breastfeeding women.
- Excessive alcohol consumption or drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Life Science Innovation Hub
Calgary
Isaac Wong, 5872472660, clinical@nimblesci.com
Christopher N Andrews
About this study
This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.
- Being tested
- FiberSmart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberSmartDrug
Anderson Global's FiberSmart Formulation, branded as FiberSmart, which is a soluble tapioca fiber powder (resistant dextrin). Natural Product Number 80091222. The product is a prebiotic supplement intended for oral consumption.
PlaceboOther
Placebo: Microcrystalline Cellulose, matches for appearance and taste, and is inert without prebiotic effects.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Not described Receives: Drug: FiberSmart |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
To evaluate changes in the small intestinal microbiome of healthy participants from baseline to the end of the 21#day FiberSmart intervention, as assessed by differential abundance testing of bacterial taxa across sampling timepoints using the SIMBA capsule. Shotgun metagenomic sequencing will be used to characterize taxonomic and functional shifts in the small intestinal microbiome.
Measured: Baseline (day 0) to the end of Intervention (day 21)
Secondary outcomes (3)
Secondary 1
Assess the difference in metagenomic profile between the small intestine and stool within participants in response to the FiberSmart intervention from baseline, to the end of intervention using the SIMBA capsule.
Measured: Baseline (day 0) to the end of Intervention (day 21
Secondary 2
Assess the microbial composition (superimposability of PLS-DA mapping) of the SI from samples collected by the SIMBA capsule
Measured: Baseline (day 0) to the end of Intervention (day 21)
Secondary 3
Explore the potential impact FiberSmart has on bowel movement frequency and texture correlation using daily questionnaires
Measured: Baseline (day 0) to the end of Intervention (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrebioticsStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anderson Advanced Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788924
- Sponsor's protocol ID
- NIMCSF306
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule
- ClinicalTrials.gov ID
- NCT07788924
- Acronym / sponsor ID
- NIMCSF306
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anderson Advanced IngredientsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Aug 2026 (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 is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Drug: FiberSmart |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 19-40 years old at the inclusion of the study, both female and male subjects.
- Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.
- Willing to maintain their current lifestyle during the study.
- Able to swallow a 25mm length and 9mm width sized capsule.
- At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study.- Page 3 of 5 [DRAFT]
Key exclusion criteria (14 listed)
- Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).
- Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.
- Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.
- Less than 3 bowel movements a week
- If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after
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 |
|---|---|---|
| FiberSmartAnderson Global's FiberSmart Formulation, branded as FiberSmart, which is a soluble tapioca fiber powder (resistant dextrin). Natural Product Number 80091222. The product is a prebiotic supplement intended for oral consumption. | Drug | Prebiotic |
| PlaceboPlacebo: Microcrystalline Cellulose, matches for appearance and taste, and is inert without prebiotic effects. | Other | Placebo |
Primary outcome
Primary
Time frame: Baseline (day 0) to the end of Intervention (day 21)
To evaluate changes in the small intestinal microbiome of healthy participants from baseline to the end of the 21#day FiberSmart intervention, as assessed by differential abundance testing of bacterial taxa across sampling timepoints using the SIMBA capsule. Shotgun metagenomic sequencing will be used to characterize taxonomic and functional shifts in the small intestinal microbiome.
3 secondary outcomes
Secondary 1
Time frame: Baseline (day 0) to the end of Intervention (day 21
Secondary 2
Time frame: Baseline (day 0) to the end of Intervention (day 21)
Secondary 3
Time frame: Baseline (day 0) to the end of Intervention (day 21)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Healthy Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FiberSmart in people with Prebiotics and Metagenomic Next Generation Sequencing, run by Anderson Advanced Ingredients at 1 site in Canada.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Aug 2026. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isaac Wong (5872472660, clinical@nimblesci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: Baseline (day 0) to the end of Intervention (day 21)). 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 27 Aug 2026.