Not yet recruitingNCT07033000Updated Jun 24, 2025

A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes and Extracts on Bloating in Adults.

An interventional study of Placebo and Dietary Supplement with actives in Healthy, sponsored by Olly, PBC. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Olly, PBC · Not applicable, Interventional, and Supportive care

From the registry’s dates

Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.

Conditions studied

Healthy

In context

Lead sponsor

Olly, PBC is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy Adults aged 18-65 years
Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months
Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
Ability to provide informed consent and comply with all protocol requirements

Exclusion criteria

Exclusion Criteria:

Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
Use of antibiotics, laxatives, or probiotics within the past 4 weeks
Uncontrolled diabetes mellitus
Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
Excessive alcohol intake (>14 drinks/week for men, >7 drinks/week for women)
Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics)
Pregnant or breastfeeding women
Use of systemic corticosteroids or immunosuppressant drugs.
History of reaction to the category of product tested
Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
Employee of CRO or product manufacturer

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Care provider)
Enrollment: 50 participants (estimated)

Study arms

Placebo comparator
Placebo
Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.
Dietary Supplement: Placebo
Active comparator
Dietary Supplement with actives
Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.
Dietary Supplement: Dietary Supplement with actives

Interventions

Dietary supplementPlacebo
Placebo
Dietary supplementDietary Supplement with actives
Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts

What researchers measure

Primary outcomes

To determine the impact of BTB on hydrogen and methane production in healthy adults
Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.
Time frame: From time of enrollement to end of study at Week4

Secondary outcomes

To estimate the changes in abdominal circumference as an indicator of distention
Standardized tape measurement at the level of the iliac crest or on top of belly button will be used to evaluate changes in abdominal distention at baseline and after the study at Week4.
Time frame: From time of enrollement to end of study at Week4
To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence.
Participants will take Visual Analogue Scale (VAS) which is a self-reported assessment of bloating and distention severity using PROMIS's GI gas and bloating questionnaire at baseline and after the study at Week4.
Time frame: From time of enrollement to end of study at Week4

Study locations

1 site

MusB Research
New Port Richey, Florida 34653, United States
- Hariom Yadav · Contact · yadavh@musbresearch.com · 240-899-5859

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07033000
Lead sponsor: Olly, PBC
Responsible party: Sponsor
First posted: Jun 24, 2025
Start date: Jul 14, 2025 (estimated)
Primary completion: Aug 25, 2025 (estimated)
Completion: Sep 15, 2025 (estimated)
Last update: Jun 24, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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