Small Intestinal Bacterial Overgrowth Syndrome (SIBO)AV1-SIBONCT07215676
A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
A study testing AV1PD1A in people with Small Intestinal Bacterial Overgrowth Syndrome (SIBO) and Small Intestinal Bacterial Overgrowth, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The goal of this trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO). The main questions the study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Intestinal Bacterial Overgrowth
- What is being tested?
- AV1PD1A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 25 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years.
- Meets North American Consensus criteria for hydrogen-dominant SIBO by lactulose breath test.
- Willing to: take study supplement (3 caps/day for 8 weeks); complete two lactulose breath tests with required prep/fast; undergo three fasting blood draws; complete questionnaires.
- Able to provide informed consent and communicate in English.
- Individuals of child-bearing potential agree to use effective contraception during the study.
Who cannot join
- Recent antibiotics/antifungals/supplements that confound breath test results (e.g., antibiotics within 14 days before breath test; current systemic or topical antifungals).
- Recent changes in diet/medications/supplement regimen within 30 days.
- Hospitalization within past 3 months.
- Allergy/intolerance to product components (e.g., Saccharomyces, Lactobacillus, shellfish [for N-acetyl-glucosamine], ginger, or berberine).
- Renal/hepatic abnormalities at screening (e.g., eGFR <60 mL/min/1.73 m2; AST/ALT/bilirubin outside of normal reference ranges).
- Hepatitis from any cause; excessive alcohol use (>7 drinks/week women; > 14 drinks/week men).
- Medications with concerning interactions after clinical investigator review
Trial locations and contacts
1 site in 1 country.
United States1 site
NUNM - Helfgott Research Institute
Portland, Oregon, 97201
About this study
Official title: An Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
The goal of this trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO).
The main questions the study aims to answer are:
Read more
- Is the product safe and well-tolerated over 8 weeks, as measured by bloodwork, vital signs, and adverse effects?
- How many participants adhere to the intervention without a dose modification, hold, or discontinuation?
Exploratory questions include: do GI symptoms and quality of life ratings improve, and do hydrogen/methane levels on lactulose breath testing change from baseline to week 8?
There is no comparison group; this is a prospective, open-label, single-arm pilot trial (n=10).
Participants will:
- Be screened and confirmed to have hydrogen-dominant SIBO by lactulose breath test (with 24-hour prep diet and overnight fast).
- Take AV1PD1A, three capsules daily for 8 weeks.
- Attend three clinic visits at baseline, week 4, and week 8 for vital measurements, fasting blood draws, and adverse event checks.
- Complete questionnaires on symptoms and quality of life.
- Repeat the lactulose breath test at week 8 to assess changes in hydrogen and methane.
Read the detailed description
Prospective, single-site, open-label, single-group pilot conducted at NUNM's Helfgott Research Institute (Portland, OR). The investigational product (AV1PD1A) is a multi-component dietary supplement containing Saccharomyces cerevisiae fermentate (EpiCor), N-acetyl-glucosamine, Saccharomyces boulardii, Lactobacillus rhamnosus (heat-killed), methylcobalamin, berberine, and gingerol (ginger extract). Dosing: 3 capsules daily for 8 weeks. Primary outcome is safety/tolerability (labs, vitals, AEs). Exploratory outcomes include validated PROMIS instruments, IBS Adequate Relief, and changes in lactulose breath-test hydrogen/methane. Enrollment is single-arm with anticipated n = 10 (pilot) to establish feasibility/tolerability signals that inform future powered trials.
- Conditions
- Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Intestinal Bacterial Overgrowth
- Being tested
- AV1PD1A
- Keywords
- SIBO, small intestinal bacterial overgrowth, hydrogen SIBO, dysbiosis, probiotic, postbiotic
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV1PD1ADietary supplement
Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, Saccharomyces boulardii, heat-killed Lactobacillus rhamnosus, methylcobalamin, berberine, ginger extract
| Study group | Role | What they receive |
|---|---|---|
| AV1PD1A | Experimental | Multi-component dietary supplement taken 3 capsules daily for 8 weeks Receives: Dietary Supplement: AV1PD1A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
The number of participants experiencing ≥1 treatment-emergent AE from first dose through end of treatment. Severity graded using CTCAE v5.0 (scale 1-5; 1 is least severe, 5 is most); relatedness assessed by the investigator. Report number of participants with any treatment-emergent AE and summarize by worst grade and relatedness.
Measured: From baseline/enrollment to the end of treatment at 8 weeks
Number of participants with laboratory abnormalities meeting pre-specified hold/stop criteria
Count of participants who meet any lab-based stopping rule (e.g., ALT/AST ≥3× ULN, total bilirubin ≥2× ULN, ALP ≥2× ULN with cholestatic pattern, eGFR <60 mL/min/1.73 m² on repeat or ≥50% decline from baseline, ANC <1,000/µL, Hgb <8 g/dL, platelets <50,000/µL). ULN/LLN per local lab report.
Measured: Screening/baseline, Week 4, and Week 8
Number of participants requiring any dose modification/temporary hold/discontinuation
Count of participants who undergo a dose reduction, temporary hold, or permanent discontinuation of the study product per the prespecified dose-modification algorithm (triggered by AEs or labs).
Measured: From first dose (Week 0) through end of treatment at Week 8.
Change in Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 domain T-scores
T-scores range from 22.5 minimum to 79.4 maximum. For symptom domains (e.g., Pain Interference, Anxiety, Depression, Fatigue, Sleep Disturbance), higher scores = worse symptoms; for function domains (Physical Function; Ability to Participate in Social Roles and Activities), higher scores = better function. Outcome is a mean change from baseline to Week 8 for the specified single domain.
Measured: From baseline/enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Change in PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score
T-score range 20-80; higher = worse gas/bloating. Outcome is mean change from baseline to Week 8.
Measured: From baseline/enrollment to the end of treatment at 8 weeks
Change in PROMIS® Gastrointestinal Belly Pain Short Form 6a T-score
T-score range 20-80; higher = worse belly pain. Outcome is mean change from baseline to Week 8.
Measured: From baseline/enrollment to the end of treatment at 8 weeks
IBS-Adequate Relief (IBS-AR)
Proportion reporting adequate symptom relief at Week 4 and Week 8. The scale is a single dichotomous (yes/no) outcome from the question "Over the past week have you had adequate relief of your IBS symptoms?"
Measured: From baseline/enrollment to week 4, to the end of treatment at 8 weeks.
Change in 0-90-minute hydrogen rise (ppm) on lactulose breath test
Mean change in 0-90 min hydrogen rise (ppm) from baseline to Week 8.
Measured: From baseline/enrollment to the end of treatment at 8 weeks
Change in peak methane (ppm) on lactulose breath test
Mean change in peak methane (ppm) from baseline to Week 8. (Consensus: ≥10 ppm at any time indicates methane-positive.)
Measured: From baseline/enrollment to the end of treatment at 8 weeks
Number of participants with a negative lactulose breath test at Week 8
Count of participants meeting negative criteria at Week 8 (e.g., hydrogen rise <20 ppm (0-90 min) and methane <10 ppm at all time points), per consensus thresholds.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start10 Oct 2025
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial Overgrowth Syndrome (SIBO)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brice Thompson, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215676
- Sponsor's protocol ID
- JG72425
- Acronym
- AV1-SIBO
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate, de-identified results will be disseminated; IPD may be considered upon reasonable request and IRB/DUA approvals
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT07215676
- Acronym / sponsor ID
- AV1-SIBO / JG72425
- Conditions
- Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Intestinal Bacterial Overgrowth
- Keywords
- SIBO, small intestinal bacterial overgrowth, hydrogen SIBO, dysbiosis, probiotic, postbiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 10 Oct 2025 (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 trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO).
The main questions the study aims to answer are:
- Is the product safe and well-tolerated over 8 weeks, as measured by bloodwork, vital signs, and adverse effects?
- How many participants adhere to the intervention without a dose modification, hold, or discontinuation?
Exploratory questions include: do GI symptoms and quality of life ratings improve, and do hydrogen/methane levels on lactulose breath testing change from baseline to week 8?
There is no comparison group; this is a prospective, open-label, single-arm pilot trial (n=10).
Participants will:
- Be screened and confirmed to have hydrogen-dominant SIBO by lactulose breath test (with 24-hour prep diet and overnight fast).
- Take AV1PD1A, three capsules daily for 8 weeks.
- Attend three clinic visits at baseline, week 4, and week 8 for vital measurements, fasting blood draws, and adverse event checks.
- Complete questionnaires on symptoms and quality of life.
- Repeat the lactulose breath test at week 8 to assess changes in hydrogen and methane.
Detailed description
Prospective, single-site, open-label, single-group pilot conducted at NUNM's Helfgott Research Institute (Portland, OR). The investigational product (AV1PD1A) is a multi-component dietary supplement containing Saccharomyces cerevisiae fermentate (EpiCor), N-acetyl-glucosamine, Saccharomyces boulardii, Lactobacillus rhamnosus (heat-killed), methylcobalamin, berberine, and gingerol (ginger extract). Dosing: 3 capsules daily for 8 weeks. Primary outcome is safety/tolerability (labs, vitals, AEs). Exploratory outcomes include validated PROMIS instruments, IBS Adequate Relief, and changes in lactulose breath-test hydrogen/methane. Enrollment is single-arm with anticipated n = 10 (pilot) to establish feasibility/tolerability signals that inform future powered trials.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AV1PD1A | Experimental | Dietary Supplement: AV1PD1AMulti-component dietary supplement taken 3 capsules daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years.
- Meets North American Consensus criteria for hydrogen-dominant SIBO by lactulose breath test.
- Willing to: take study supplement (3 caps/day for 8 weeks); complete two lactulose breath tests with required prep/fast; undergo three fasting blood draws; complete questionnaires.
- Able to provide informed consent and communicate in English.
- Individuals of child-bearing potential agree to use effective contraception during the study.
Key exclusion criteria (7 listed)
- Recent antibiotics/antifungals/supplements that confound breath test results (e.g., antibiotics within 14 days before breath test; current systemic or topical antifungals).
- Recent changes in diet/medications/supplement regimen within 30 days.
- Hospitalization within past 3 months.
- Allergy/intolerance to product components (e.g., Saccharomyces, Lactobacillus, shellfish [for N-acetyl-glucosamine], ginger, or berberine).
- Renal/hepatic abnormalities at screening (e.g., eGFR <60 mL/min/1.73 m2; AST/ALT/bilirubin outside of normal reference ranges).
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 |
|---|---|---|
| AV1PD1ASaccharomyces cerevisiae fermentate, N-acetyl-glucosamine, Saccharomyces boulardii, heat-killed Lactobacillus rhamnosus, methylcobalamin, berberine, ginger extract | Dietary supplement | AV1PD1A |
Primary outcome
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
The number of participants experiencing ≥1 treatment-emergent AE from first dose through end of treatment. Severity graded using CTCAE v5.0 (scale 1-5; 1 is least severe, 5 is most); relatedness assessed by the investigator. Report number of participants with any treatment-emergent AE and summarize by worst grade and relatedness.
Number of participants with laboratory abnormalities meeting pre-specified hold/stop criteria
Time frame: Screening/baseline, Week 4, and Week 8
Count of participants who meet any lab-based stopping rule (e.g., ALT/AST ≥3× ULN, total bilirubin ≥2× ULN, ALP ≥2× ULN with cholestatic pattern, eGFR <60 mL/min/1.73 m² on repeat or ≥50% decline from baseline, ANC <1,000/µL, Hgb <8 g/dL, platelets <50,000/µL). ULN/LLN per local lab report.
Number of participants requiring any dose modification/temporary hold/discontinuation
Time frame: From first dose (Week 0) through end of treatment at Week 8.
Count of participants who undergo a dose reduction, temporary hold, or permanent discontinuation of the study product per the prespecified dose-modification algorithm (triggered by AEs or labs).
Change in Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 domain T-scores
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
T-scores range from 22.5 minimum to 79.4 maximum. For symptom domains (e.g., Pain Interference, Anxiety, Depression, Fatigue, Sleep Disturbance), higher scores = worse symptoms; for function domains (Physical Function; Ability to Participate in Social Roles and Activities), higher scores = better function. Outcome is a mean change from baseline to Week 8 for the specified single domain.
6 secondary outcomes
Change in PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
Change in PROMIS® Gastrointestinal Belly Pain Short Form 6a T-score
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
IBS-Adequate Relief (IBS-AR)
Time frame: From baseline/enrollment to week 4, to the end of treatment at 8 weeks.
Change in 0-90-minute hydrogen rise (ppm) on lactulose breath test
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
Change in peak methane (ppm) on lactulose breath test
Time frame: From baseline/enrollment to the end of treatment at 8 weeks
Number of participants with a negative lactulose breath test at Week 8
Time frame: Week 8
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 12 May 2026.
- Individual participant dataSharing planned: No. Aggregate, de-identified results will be disseminated; IPD may be considered upon reasonable request and IRB/DUA approvals
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AV1PD1A in people with Small Intestinal Bacterial Overgrowth Syndrome (SIBO) and Small Intestinal Bacterial Overgrowth, run by National University of Natural Medicine 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 5 inclusion and 7 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 12 May 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 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?
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events) (time frame: From baseline/enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. 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 12 May 2026.