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

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.