BloatingNCT06642766
Fiber Product for Gas, Bloating, and Bowel Regularity
A study testing Fiber supplement in people with Bloating and Bowel Irregularities, run by Bell Cinical Service at 1 site in United States.
Trial summary
This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bloating, Bowel Irregularities, Bowel Gas
- What is being tested?
- Fiber supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to May 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects have experienced two or more of the following criteria for at least 3 months with symptom onset at least 6 months prior: straining during at least 25% of defecations, lumpy or hard stools in at least 25% of defecations, sensation of incomplete evacuation for at least 25% of defecations, sensation of anorectal obstruction/blockage for at least 25% of defecations, manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor), loose stools are rarely present without the use of laxatives Or,
- Subjects have experienced 2 or more of the following criteria of recurrent abdominal pain, for at least 3 months, with symptom onset at least 6 months prior: pain related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool Or,
- Subjects have experienced 2 or more of the following criteria for at least 3 months, with symptom onset at least 6 months prior: recurrent abdominal pain, on average, at least 1 day per week in the last 3 months associated with two of the following criteria: pain related to defecation, pain associated with a change in frequency of stool and pain associated with a change in form (appearance) of stool.
- The subject predominantly experiences loose or watery stools (Bristol Stool Form Scale types 6-7), more than 25% of the time, or hard or lumpy stools (types 1-2) less than 25% of the time.
- The symptoms should be chronic and interfere with daily activities, cause worry or affect the quality of life.
Who cannot join
- Loose stools are present for more than 25% of defecations
- Unable to provide informed consent
- Hematochezia
- Prior colon surgery
- Thyroid disease
- Pelvic floor disorder
Show all 10Show fewer
- Known allergies or intolerance to fiber products
- infectious diarrhea or food poisoning
- inflammatory bowel disease, including microscopic colitis
- fecal incontinence or rectal prolapse
Trial locations and contacts
1 site in 1 country.
United States1 site
XL Medical
Edina, Minnesota, 55435
Robert Ganz, MD, 802-272-7374, bob@ganzindustries.com
Aundria Riggen, PA, 218-591-2958, aundria@lx-medical.com
About this study
Official title: Open Label Study of a Novel, Commercially Available Fiber Product for Gas, Bloating, and Bowel Regularity
This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. The purpose of this study is to evaluate the effects of a new fiber product on bloating, gas, and bowel movements.
- Conditions
- Bloating, Bowel Irregularities, Bowel Gas
- Being tested
- Fiber supplement
- Keywords
- fiber supplement, bloating, nutralieve, Microbiome, Gut microbiota, irregular bowel movements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber supplementDietary supplement
Subjects that meet the inclusion criteria and with symptoms appropriate for fiber supplementation are eligible to participate. Participants will be instructed to use the fiber product (NutraLieve) as currently labeled; start with a dosage of 4-5 grams per day (one heaping teaspoon), initially taken once daily, increasing up to 3 heaping teaspoons a day (maximum dose 15 grams/day) on an as needed basis.Participants will be prospectively assessed for symptoms at baseline and at 6 weeks.
- The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary.
- Secondary endpoints, reduction in bloating or gas, or any adverse events will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.
| Study group | Role | What they receive |
|---|---|---|
| Fiber supplemenmt | Experimental | Not described Receives: Dietary Supplement: Fiber supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bowel movement
- The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary.
Measured: 6 weeks
Secondary outcomes (2)
Bloating
- Reduction in bloating will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.
Measured: 6 weeks
Gas
Reduction in gas will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloatingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bell Cinical Service
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LX Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642766
- Sponsor's protocol ID
- 20243173
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subject's demographics and measured outcomes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of a Novel, Commercially Available Fiber Product for Gas, Bloating, and Bowel Regularity
- ClinicalTrials.gov ID
- NCT06642766
- Acronym / sponsor ID
- 20243173
- Conditions
- Bloating, Bowel Irregularities, Bowel Gas
- Keywords
- fiber supplement, bloating, nutralieve, Microbiome, Gut microbiota, irregular bowel movements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bell Cinical ServiceIndustry (pharma, biotech, devices)
- Collaborators
- LX Medical
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Oct 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.
This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. The purpose of this study is to evaluate the effects of a new fiber product on bloating, gas, and bowel movements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiber supplemenmt | Experimental | Dietary Supplement: Fiber supplement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects have experienced two or more of the following criteria for at least 3 months with symptom onset at least 6 months prior: straining during at least 25% of defecations, lumpy or hard stools in at least 25% of defecations, sensation of incomplete evacuation for at least 25% of defecations, sensation of anorectal obstruction/blockage for at least 25% of defecations, manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor), loose stools are rarely present without the use of laxatives Or,
- Subjects have experienced 2 or more of the following criteria of recurrent abdominal pain, for at least 3 months, with symptom onset at least 6 months prior: pain related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool Or,
- Subjects have experienced 2 or more of the following criteria for at least 3 months, with symptom onset at least 6 months prior: recurrent abdominal pain, on average, at least 1 day per week in the last 3 months associated with two of the following criteria: pain related to defecation, pain associated with a change in frequency of stool and pain associated with a change in form (appearance) of stool.
- The subject predominantly experiences loose or watery stools (Bristol Stool Form Scale types 6-7), more than 25% of the time, or hard or lumpy stools (types 1-2) less than 25% of the time.
- The symptoms should be chronic and interfere with daily activities, cause worry or affect the quality of life.
Key exclusion criteria (10 listed)
- Loose stools are present for more than 25% of defecations
- Unable to provide informed consent
- Hematochezia
- Prior colon surgery
- Thyroid 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 |
|---|---|---|
| Fiber supplementSubjects that meet the inclusion criteria and with symptoms appropriate for fiber supplementation are eligible to participate. Participants will be instructed to use the fiber product (NutraLieve) as currently labeled; start with a dosage of 4-5 grams per day (one heaping teaspoon), initially taken once daily, increasing up to 3 heaping teaspoons a day (maximum dose 15 grams/day) on an as needed basis.Participants will be prospectively assessed for symptoms at baseline and at 6 weeks. * The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary. * Secondary endpoints, reduction in bloating or gas, or any adverse events will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary. | Dietary supplement | Fiber supplemenmt |
Primary outcome
Number of bowel movement
Time frame: 6 weeks
- The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary.
2 secondary outcomes
Bloating
Time frame: 6 weeks
Gas
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. Subject's demographics and measured outcomes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber supplement in people with Bloating and Bowel Irregularities, run by Bell Cinical Service 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 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: status not confirmed, as of the sponsor's last update on 15 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Ganz, MD (802-272-7374, bob@ganzindustries.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bowel movement (time frame: 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 15 Oct 2024.