Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Dietary Supplement with Active Ingredient Blend

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94127
      • See Final Report

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning.	Dietary supplement: Placebo; Eligible subjects will receive Placebo to take daily for six weeks
Active Comparator: Dietary Supplement with Active Ingredient Blend; Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning.	Dietary supplement: Dietary Supplement with Active Ingredient Blend; Eligible subjects will receive Active supplement to take daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores	To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group	from enrollment to end of study at 8 weeks
Changes in Symptom Severity Score (Diary)	Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group	from enrollment to end of study at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores	To assess changes in gastrointestinal symptoms comparing active supplement to placebo group	from enrollment to end of study at 8 weeks
Changes in Stool Consistency (Bristol Stool Scale)	Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.	from enrollment to end of study at 8 weeks

Collaborators and Investigators

• Sponsor: Olly, PBC

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Dilatation, Pathologic
• Other Study ID Numbers: UNLV20231116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No