Clinical trial NCT06808867: Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms
Official title: A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Olly, PBC
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.

Study Primary Objective:

• To assess improvement in bloating symptoms

Study Secondary Objectives:

* To assess safety and tolerability of the formulation
* To compare the time taken for perceptual improvement in bloating/distention
* Enzyme blood assays
* To assess quality of life indices


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study.
* Willingness to actively participate in the study and to come to the scheduled visits.
* Female and/or male
* From 18 to 85 years of age
* Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks

Exclusion Criteria:

* Drug addicts, alcoholics.
* AIDS, HIV-positive or infectious hepatitis
* Diabetes mellitus
* Disorders known to affect GI motility such as gastroparesis or amyloidosis.
* Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease
* History of surgery known to alter the normal function of the GI tract.
* Conditions which exclude participation or might influence the test reaction/evaluation.
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
* Documented allergies to cosmetic products and/or ingredients
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.
* Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study
* Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study
* Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.
* One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.

Primary outcomes:
measure: Changes in Digestive Quality of Life Questionnaire (DQLQ) scores
timeFrame: from enrollment to end of study at 8 weeks
measure: Changes in Symptom Severity Score (Diary)
timeFrame: from enrollment to end of study at 8 weeks
Secondary outcomes:
measure: Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores
timeFrame: from enrollment to end of study at 8 weeks
measure: Changes in Stool Consistency (Bristol Stool Scale)
timeFrame: from enrollment to end of study at 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: See Final Report
state: California
Study officials:
References: