Irritable Bowel Syndrome-bile Acid DiarrheaNCT06028035
A Study of Hemp Hull WFI for IBS Diarrhea
A study testing BB01 in people with Irritable Bowel Syndrome-bile Acid Diarrhea, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome-bile Acid Diarrhea
- What is being tested?
- BB01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 1 May 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior diagnosis of bile acid diarrhea as documented by either
- total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
- greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
- greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
- serum 7 alpha C4 greater than 52 ng/mL
- BMI <40 kg/m2.
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- Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
- Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
- No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment
Who cannot join
- Diabetes mellitus (type 1)
- Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
- Uncontrolled hypertension (with BP measured >140/90mmHg in the CRTU)
- BMI ≥40 kg/m2
- Chronic NSAID use (>1 day/week)
- Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
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- Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
- Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks;
- Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study
- Participation in highly vigorous exercise such as running >5 miles per day in week prior to the permeability test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals.
Read the detailed description
Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.
To demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.
- Being tested
- BB01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB01Dietary supplement
20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.
| Study group | Role | What they receive |
|---|---|---|
| BB01 Supplement Bars | Experimental | Subjects will consume two BB01 supplement bars daily for 21 days. Receives: Dietary Supplement: BB01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary excretion of 13^C-mannitol
Percent urinary excretion of 13^C-mannitol
Measured: Baseline, 3 weeks
Change in urinary excretion of lactulose
Percent urinary excretion of lactulose
Measured: Baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start6 Oct 2023
- Primary completion31 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome-bile Acid DiarrheaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028035
- Sponsor's protocol ID
- 23-005827
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
- ClinicalTrials.gov ID
- NCT06028035
- Acronym / sponsor ID
- 23-005827
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Sep 2023 (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 purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals.
Detailed description
Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.
To demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BB01 Supplement Bars | Experimental | Dietary Supplement: BB01Subjects will consume two BB01 supplement bars daily for 21 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Prior diagnosis of bile acid diarrhea as documented by either
- BMI <40 kg/m2.
- Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
- Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
- No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment
Key exclusion criteria (10 listed)
- Diabetes mellitus (type 1)
- Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
- Uncontrolled hypertension (with BP measured >140/90mmHg in the CRTU)
- BMI ≥40 kg/m2
- Chronic NSAID use (>1 day/week)
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 |
|---|---|---|
| BB0120 grams minimally processed form of Hemp hulls in the form of a bar/wafer. | Dietary supplement | BB01 Supplement Bars |
Primary outcome
Change in urinary excretion of 13^C-mannitol
Time frame: Baseline, 3 weeks
Percent urinary excretion of 13^C-mannitol
Change in urinary excretion of lactulose
Time frame: Baseline, 3 weeks
Percent urinary excretion of lactulose
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 5 Jun 2024.
- Individual participant dataSharing planned: No
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.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BB01 in people with Irritable Bowel Syndrome-bile Acid Diarrhea, run by Mayo Clinic 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 9 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 5 Jun 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. 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 urinary excretion of 13^C-mannitol (time frame: Baseline, 3 weeks). The study lists 2 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 5 Jun 2024.