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

Olly, PBC

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Dietary Supplement with Active Ingredient Blend

Study type

Interventional

Funder types

Industry

Identifiers

NCT06808867

UNLV20231116

Details and patient eligibility

About

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

Enrollment

85 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.