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

NCT06808867 | Completed

• 1 other identifier: UNLV20231116
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores

  from enrollment to end of study at 8 weeks

• Changes in Stool Consistency (Bristol Stool Scale)

  from enrollment to end of study at 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning.

Dietary Supplement: Placebo

Dietary Supplement with Active Ingredient Blend

ACTIVE COMPARATOR

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

Interventions

Placebo DIETARY_SUPPLEMENT

Eligible subjects will receive Placebo to take daily for six weeks

Placebo

Dietary Supplement with Active Ingredient Blend DIETARY_SUPPLEMENT

Eligible subjects will receive Active supplement to take daily for six weeks

Dietary Supplement with Active Ingredient Blend

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

See Final Report

San Francisco, California, 94127, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 25, 2024
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

US (1)