Gut HealthNCT07755735
A Study to Evaluate the Effects of a Fiber Supplement on Gut Health
A study testing Active Supplement in people with Gut Health and Bloating, run by Belli Welli Inc. at 1 site in United States.
Trial summary
This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gut Health, Bloating, Irregular Bowel Movements
- What is being tested?
- Active Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 12 Jan 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
- Be male or female
- Be aged 18 or older
- Experiencing issues regarding all of the following over the past 4 weeks: bloating, irregular bowel movements, and self-perceived poor gut health
- Generally healthy - does not live with any uncontrolled chronic disease
- Willing to discontinue any other supplements or herbal remedies that target gut or digestive health
- Not planning on introducing any products or any new forms of prescription medication or supplements that target gut health for the study duration
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- Willing to maintain current diet, sleep pattern, and activity levels for the duration
- Resides in the United States
- Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration
Who cannot join
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries
- Anyone with any allergies or sensitivities to any of the study product ingredients
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone who is vegan and/or does not consume animal products for any reasons
- Anyone unwilling to follow the study protocol
- Anyone with a history of substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo product, taken twice daily.
Participants will complete questionnaires and provide waist and body composition measurements at Baseline, Week 4, Week 8, and Week 12. The primary outcomes include changes in overall gut health scores, waist circumference, and body composition. Secondary outcomes include participant-perceived effects on bloating, regularity, hydration, energy, and hair, skin, and nail support.
- Being tested
- Active Supplement, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SupplementDietary supplement
Participants receive BelliWelli Daily Fiber + Probiotics supplement containing Collagen Peptides (Bovine) (2 g), Niacin as Niacinamide (7.5 mg), Magnesium as Magnesium Citrate (75 mg), Sodium as Sea Salt (75 mg), Potassium as Potassium Chloride (100 mg), Bacillus coagulans MTCC 5856 (10 mg / 1 billion CFU), and Acacia Fiber (4.0 g), consumed twice per day for 12 weeks.
Placebo ComparatorDietary supplement
Participants receive a taste- and appearance-matched placebo product containing Maltodextrin, Organic Cane Sugar, Natural Flavors, Citric Acid, Malic Acid, Silicon Dioxide, Stevia Leaf Extract, Beet Juice (color), and Fruit and Vegetable Juice (color), consumed twice per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Supplement | Experimental | Not described Receives: Dietary Supplement: Active Supplement |
| Placebo Comparator | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Gut Health Score
Mean change in GSRS (Gastrointestinal Symptoms Rating Scale) total score from baseline as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Bowel Movement Quality
Mean change in stool form and consistency as assessed via the Bristol Stool Scale self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hydration
Mean change in self-reported hydration as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Bloating
Mean change in self-reported bloating as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Waist Circumference
Mean change in waist circumference from baseline as assessed via tape measure waist measurement
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Body Weight
Mean change in body weight from baseline as assessed via Withings Smart Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Muscle Mass
Mean change in muscle mass from baseline as assessed via Withings Smart Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fat Mass
Mean change in fat mass from baseline as assessed via Withings Smart Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Visceral Fat Mass
Mean change in visceral fat mass from baseline as assessed via Withings Smart Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (7)
Change in Self-Reported Regularity
Mean change in participant-perceived bowel movement regularity as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hydration
Mean change in participant-perceived hydration as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Stool Feeling
Mean change in participant-perceived stool feeling as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Energy Levels
Mean change in participant-perceived energy levels as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hair
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Skin
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Nail Support
Mean change in participant-perceived hair, skin, and nail support as assessed via self-reported questionnaire
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start26 Aug 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belli Welli Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755735
- Sponsor's protocol ID
- 20719
- Other IDs
- legacy-20719
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of a Fiber Supplement on Gut Health
- ClinicalTrials.gov ID
- NCT07755735
- Acronym / sponsor ID
- 20719
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Belli Welli Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 10 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, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo product, taken twice daily.
Participants will complete questionnaires and provide waist and body composition measurements at Baseline, Week 4, Week 8, and Week 12. The primary outcomes include changes in overall gut health scores, waist circumference, and body composition. Secondary outcomes include participant-perceived effects on bloating, regularity, hydration, energy, and hair, skin, and nail support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Supplement | Experimental | Dietary Supplement: Active Supplement |
| Placebo Comparator | Placebo comparator | Dietary Supplement: Placebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be male or female
- Be aged 18 or older
- Experiencing issues regarding all of the following over the past 4 weeks: bloating, irregular bowel movements, and self-perceived poor gut health
- Generally healthy - does not live with any uncontrolled chronic disease
- Willing to discontinue any other supplements or herbal remedies that target gut or digestive health
Key exclusion criteria (7 listed)
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries
- Anyone with any allergies or sensitivities to any of the study product ingredients
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone who is vegan and/or does not consume animal products for any reasons
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 |
|---|---|---|
| Active SupplementParticipants receive BelliWelli Daily Fiber + Probiotics supplement containing Collagen Peptides (Bovine) (2 g), Niacin as Niacinamide (7.5 mg), Magnesium as Magnesium Citrate (75 mg), Sodium as Sea Salt (75 mg), Potassium as Potassium Chloride (100 mg), Bacillus coagulans MTCC 5856 (10 mg / 1 billion CFU), and Acacia Fiber (4.0 g), consumed twice per day for 12 weeks. | Dietary supplement | Active Supplement |
| Placebo ComparatorParticipants receive a taste- and appearance-matched placebo product containing Maltodextrin, Organic Cane Sugar, Natural Flavors, Citric Acid, Malic Acid, Silicon Dioxide, Stevia Leaf Extract, Beet Juice (color), and Fruit and Vegetable Juice (color), consumed twice per day for 12 weeks. | Dietary supplement | Placebo Comparator |
Primary outcome
Change in Overall Gut Health Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in GSRS (Gastrointestinal Symptoms Rating Scale) total score from baseline as assessed via self-reported questionnaire
Change in Bowel Movement Quality
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in stool form and consistency as assessed via the Bristol Stool Scale self-reported questionnaire
Change in Self-Reported Hydration
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported hydration as assessed via self-reported questionnaire
Change in Self-Reported Bloating
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported bloating as assessed via self-reported questionnaire
Change in Waist Circumference
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in waist circumference from baseline as assessed via tape measure waist measurement
Change in Body Weight
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in body weight from baseline as assessed via Withings Smart Scale
Change in Muscle Mass
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in muscle mass from baseline as assessed via Withings Smart Scale
Change in Fat Mass
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in fat mass from baseline as assessed via Withings Smart Scale
Change in Visceral Fat Mass
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in visceral fat mass from baseline as assessed via Withings Smart Scale
7 secondary outcomes
Change in Self-Reported Regularity
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hydration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Stool Feeling
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Energy Levels
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Hair
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Skin
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Self-Reported Nail Support
Time frame: Baseline, Week 4, Week 8, and Week 12
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 10 Aug 2026.
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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 Active Supplement in people with Gut Health and Bloating, run by Belli Welli Inc. 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 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 10 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 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. 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.
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 Overall Gut Health Score (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 9 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 10 Aug 2026.